An interventional study of Boston Scientific Vercise PC IPG with directional DBS lead in Parkinson Disease, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the clinical efficacy of directional DBS electrode technology and whether electrophysiology biomarkers can predict effective contact segments for chronic therapy.
Although deep brain stimulation (DBS) can be remarkable for treating symptoms of Parkinson's disease, improvement varies across clinical trials, individual patients, and over time. A major limitation to the advancement of DBS therapy is that there are no established biomarkers to tailor stimulator settings in individuals. Emerging segmented ("directional") lead technology allows current steering, a new opportunity to improve tolerability and efficacy by shaping the DBS electrical field. This novel lead design has 8 contacts rather than the 4 available with currently available leads. How do the investigators optimally adjust stimulation parameters when there are far more potentially useful settings than can be practically evaluated in clinic? How do the investigators know that DBS settings in a given patient are optimal or appropriate? The investigators have pioneered minimally invasive, rapidly acquired biomarkers to solve these important problems. Using electrocorticography, electroencephalography, and subcortical local field potentials, the investigators will measure whether resting or stimulus-evoked electrophysiology can serve as a predictive biomarker to guide activation and adjustment of a directional DBS system. The purpose of this randomized, double-blind crossover study is to measure the clinical efficacy of directional versus omnidirectional stimulation and to explore whether electrophysiology biomarkers can rapidly predict effective, well-tolerated contacts for directional DBS therapy.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 31 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
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Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Device: Boston Scientific Vercise PC IPG with directional DBS lead
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Device: Boston Scientific Vercise PC IPG with directional DBS lead
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Device: Boston Scientific Vercise PC IPG with directional DBS lead
Deep brain stimulation
Change From Preoperative Baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "Off" Medications
A blinded examiner will measure Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 motor scores "off" medications. MDS-UPDRS Part III is a motor examination consisting of 18 summed items where the investigator rates the severity of Parkinson's motor symptoms based on a scale of 0 - 4. Higher values indicate worse function (possible min score = 0, possible max score = 72). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Treatment Preference Survey Programming Strategy Preference
Based on overall quality of life, participants will select their preference between directional and omnidirectional DBS.
Time frame: 4 months post surgery
Change From Preoperative Baseline in the Beck Depression Inventory-2 (BDI-2)
The Beck Depression Inventory-2 is a 21 question self-report inventory which evaluates a person's severity of depression. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory is a 21 question self-report inventory which evaluates a person's severity of anxiety. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Delayed Recall Raw Score (Versions AB, CD, CR, GE)
The Auditory Verbal Learning Test (AVLT) delayed recall raw score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and later asked to recall the items on the list. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 12). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Recognition Raw Score (Versions AB, CD, CR, GE)
The Auditory Verbal Learning Test (AVLT) Recognition Raw Score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are given a list of 15 target words. The list is taken away and each is asked to now pick out the 15 target words from a larger list of 30 words. Scores indicate the overall number of target words correctly recognized (minimum = 0, maximum = 15). Higher scores indicate better performance. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Learning Raw Score (Versions AB, CD, CR, GE)
The AVLT (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and asked to immediately recall the items on the list over 6 separate trials. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 72). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Letter Fluency Test Raw Score (Version: CFL, FAS)
The Letter Fluency Test (version: CFL, FAS) evaluates the number of words beginning with the letters C, F, L, A, and S that a participant can produce in one minute (minimum = 0, maximum = infinity). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Voice Handicap Index
The Voice Handicap Index evaluates speech function with a 30-item self-administered questionnaire that asks participants to describe their voice and the effects of their voice on their lives. Participants respond on a 0 - 4 scale (minimum = 0, maximum = 120. Higher scores indicate worse functiion. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Communicative Participation Item Bank (CPIB)
The Communicative Participation Item Bank (CPIB) evaluates the extent to which communication disorders interfere with communicative participation. Participants respond on a 0 - 3 scale (minimum = 0, maximum = 30). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the 9-Hole Pegboard Test
The 9-Hole Pegboard Test evaluates one's upper extremity motor function. It is a timed test in which participants place 9 pegs in a pegboard and then remove them. Faster times indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in Gait Initiation Test
The gait initiation test evaluates the phase between standing motionless and steady-state locomotion. This is a timed test in which participants are given a go signal and the time until first stride is recorded. Faster times indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in Stepping Thresholds Test
The stepping thresholds test evaluates a person's compensatory stepping thresholds. This is a test in which the floor surface is unexpectedly moved beneath a participant. The distance a participant moves their feet in order to compensate is recorded. The smaller displacement scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in Quiet Stance Measure
The quiet stance measure evaluates a person's postural control during quiet standing. This is a measure of sway distance. Lower scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Parkinson's Disease Quality of Life
The Parkinson's Disease Quality of Life (PDQ-8) evaluates overall health status. It consists of eight questions regarding mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Participants choose answers on a scale ranging from never (0) to always (4) (minimum = 0, maximum = 32). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the the Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" Short Form
The Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" Short Form evaluates feelings that reflect a level of general satisfaction with life as well as a sense that life has purpose and meaning. Participants respond to questions on a 1-5 scale (minimum = 9, maximum = 45). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.1 "Satisfaction With Social Roles and Activities" Short Form
The Neuro-QOL Item Bank v1.1 "Satisfaction with Social Roles and Activities" short form short form evaluates one's satisfaction and discontentment with performing usual social roles and activities. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Neuro-QOL Item Bank v2.0 "Cognitive Function" Short Form
The Neuro-QOL Item Bank v2.0 ""Cognitive Function" short form evaluates mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" Short Form
The Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" short form evaluates functioning of one's lower extremities. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" Short Form
The Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" short form evaluates functioning of one's upper extremity function in fine motor and ADL capabilities. Participants respond to questions on a 1-5 scale (minimum = 9, maximum = 45). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Stigma" Short Form
The Neuro-QOL Item Bank v1.0 "Stigma" short form evaluates one's sensitivity of illness-related stigma. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Neuro-QOL Scale v1.0 "Communication" Short Form
The Neuro-QOL Scale v1.0 "Communication" short form evaluates one's difficulty with communication. Participants respond to questions on a 1-5 scale (minimum = 5, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" Short Form
Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" short form evaluates one's confidence to manage/control symptoms of frustration, disappointment, anger, and other negative emotions. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Global Health" Short Form
The PROMIS v1.0 "Global Health" short form evaluates the individual's global health. This is a 10 question scale on which 9 of the questions are answered with a 1 - 5 score. The remaining item is answered with a 0 - 10 score. (minimum = 9, maximum = 55). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 "Global Health Mental Health Score"
The (PROMIS) Scale v1.2 "Global Health" evaluates one's overall physical and mental health. This is a 10 item scale with scores ranging from 4-20. Higher scores indicate better overall health. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Ability to Participate in Social Roles and Activities" Short Form
The PROMIS v2.0 "Ability to Participate in Social Roles and Activities" short form evaluates one's perceived ability to perform one's usual social roles and activities. This is an 8 question measure and answers are given on a 1 - 5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Anxiety" Short Form
The PROMIS v1.0 "Emotional Distress - Anxiety" short form evaluates one's feelings of anxiety, such as fear and worry. This is a 7 item scale and participants answer with a 1 - 5 score for each item (minimum = 7, maximum = 35). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Depression" Short Form
The PROMIS v1.0 "Emotional Distress - Depression" short form evaluates one's feelings of negative mood and depression. This is an 8 item scale and participants answer with a 1 - 5 score for each item (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Fatigue" Short Form
The PROMIS v1.0 "Fatigue" short form evaluates one's range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. This is a 6 item scale and participants answer with a 1 - 5 score for each item (minimum = 6, maximum = 30). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Physical Function" Short Form
The PROMIS v2.0 "Physical Function" short form measures self-reported capability rather than actual performance of physical activities. This is a 10 item scale and participants answer with a 1 - 5 score for each item (minimum = 10, maximum = 50). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement
The PROMIS v1.0 "Pain Interference" short form evaluates the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. This is a 6 item scale and participants answer with a 1 - 5 score for each item (minimum = 6, maximum = 30). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Sleep Disturbance" Short Form
The PROMIS v1.0 "Sleep Disturbance" short form evaluates one's perceptions of sleep quality. This is an 8 item scale and participants answer with a 1 - 5 score for each item (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Dimensional Change Card Sort Score
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. On this test participants are asked to match pictures to a category and receive one point for each correct match (minimum = 0, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Flanker Test Score
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The Flanker Test is a test in which participants are asked to focus on a particular stimulus while inhibiting attention to another. An accuracy score is derived by calculating (Accuracy Score = 0.125 \* Number of Correct Responses) (minimum=0, maximum=5). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in NIH Toolbox Cognition Battery List Sorting Working Memory Test Score
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The list sorting working memory test is a test in which lists of items are presented and participants are asked to recall items from the list in a particular order. Scoring is done based on the number of items correctly recalled and sequenced (minimum = 0, maximum = 26). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Oral Reading Test Score
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The oral reading recognition test is a test in which participants are asked to read and pronounce words as accurately as possible. Pronunciation is judged by the test administrator and a score is given to each response (minimum = 0, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Pattern Comparison Test Score
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The pattern comparison test is a test in which participants are presented with two pictures and are asked to discern whether they are he same or different. Correct answers are given one point for up to a maximum of 130 trials (minimum = 0, maximum = 130). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Picture Sequencing Test Score
The picture sequencing test is a test of episodic memory in which participants are asked to recall increasingly lengthy series of illustrated objects and activities that are presented in a particular order on a computer screen. Participants are given credit for each adjacent pair of pictures they correctly place up to the maximum value for the sequence, which is one less than the sequence length (minimum = 0, maximum = 105). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Picture Vocabulary Test Score
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The picture vocabulary test is a test in which participants are presented with an audio recording of a word and four photographic images on the computer screen and asked to select the picture that most closely matches the meaning of the word (minimum = 0, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Time frame: 2, 4, and 6 months post op
| Milestone | Directional DBS by Behavior; Omnidirectional DBS by Behavior; Directional DBS by Biomarkers Last | Omnidirectional DBS by Behavior; Directional DBS by Behavior; Directional DBS by Biomarkers Last | Either Directional DBS or Omnidirectional DBS by Behavior; Directional DBS by Biomarkers Last |
|---|---|---|---|
| Started | 17 | 14 | 0 |
| Completed | 17 | 14 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Directional DBS by Behavior; Omnidirectional DBS by Behavior; Directional DBS by Biomarkers Last | Omnidirectional DBS by Behavior; Directional DBS by Behavior; Directional DBS by Biomarkers Last | Either Directional DBS or Omnidirectional DBS by Behavior; Directional DBS by Biomarkers Last |
|---|---|---|---|
| Started | 14 | 17 | 0 |
| Completed | 14 | 17 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Directional DBS by Behavior; Omnidirectional DBS by Behavior; Directional DBS by Biomarkers Last | Omnidirectional DBS by Behavior; Directional DBS by Behavior; Directional DBS by Biomarkers Last | Either Directional DBS or Omnidirectional DBS by Behavior; Directional DBS by Biomarkers Last |
|---|---|---|---|
| Started | 0 | 0 | 31 |
| Completed | 0 | 0 | 31 |
| Not completed | 0 | 0 | 0 |
A blinded examiner will measure Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 motor scores "off" medications. MDS-UPDRS Part III is a motor examination consisting of 18 summed items where the investigator rates the severity of Parkinson's motor symptoms based on a scale of 0 - 4. Higher values indicate worse function (possible min score = 0, possible max score = 72). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "Off" Medications | -16.90322581 ± 9.253305135 | -15.80645161 ± 9.257139064 | -18.33333333 ± 9.848274252 |
Based on overall quality of life, participants will select their preference between directional and omnidirectional DBS.
| Participants | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior |
|---|---|---|
| Treatment Preference Survey Programming Strategy Preference | 16 | 14 |
The Beck Depression Inventory-2 is a 21 question self-report inventory which evaluates a person's severity of depression. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Beck Depression Inventory-2 (BDI-2) | 0.965517241 ± 6.455798936 | 1.032258065 ± 5.056242814 | 0.692307692 ± 6.739550316 |
The Beck Anxiety Inventory is a 21 question self-report inventory which evaluates a person's severity of anxiety. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Beck Anxiety Inventory (BAI) | -2.55 ± 5.689093906 | -0.333333333 ± 6.32455532 | -0.6875 ± 8.16266909 |
The Auditory Verbal Learning Test (AVLT) delayed recall raw score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and later asked to recall the items on the list. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 12). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Delayed Recall Raw Score (Versions AB, CD, CR, GE) | -0.866666667 ± 3.785027976 | -0.9 ± 3.39726056 | -0.461538462 ± 3.776037809 |
The Auditory Verbal Learning Test (AVLT) Recognition Raw Score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are given a list of 15 target words. The list is taken away and each is asked to now pick out the 15 target words from a larger list of 30 words. Scores indicate the overall number of target words correctly recognized (minimum = 0, maximum = 15). Higher scores indicate better performance. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Recognition Raw Score (Versions AB, CD, CR, GE) | -0.5 ± 1.696853071 | -0.433333333 ± 1.59056124 | -0.961538462 ± 1.482720991 |
The AVLT (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and asked to immediately recall the items on the list over 6 separate trials. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 72). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Learning Raw Score (Versions AB, CD, CR, GE) | -2.233333333 ± 9.772174901 | -3.3 ± 9.203260292 | -0.576923077 ± 8.276100903 |
The Letter Fluency Test (version: CFL, FAS) evaluates the number of words beginning with the letters C, F, L, A, and S that a participant can produce in one minute (minimum = 0, maximum = infinity). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| words generated | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Letter Fluency Test Raw Score (Version: CFL, FAS) | -1.766666667 ± 8.21975473 | -1.935483871 ± 9.401898687 | -1.230769231 ± 9.074393389 |
The Voice Handicap Index evaluates speech function with a 30-item self-administered questionnaire that asks participants to describe their voice and the effects of their voice on their lives. Participants respond on a 0 - 4 scale (minimum = 0, maximum = 120. Higher scores indicate worse functiion. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Voice Handicap Index | -2.709677419 ± 9.256325939 | 0.225806452 ± 7.774786931 | -0.925925926 ± 12.04135798 |
The Communicative Participation Item Bank (CPIB) evaluates the extent to which communication disorders interfere with communicative participation. Participants respond on a 0 - 3 scale (minimum = 0, maximum = 30). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Communicative Participation Item Bank (CPIB) | -0.387096774 ± 3.489769996 | -0.741935484 ± 2.920818857 | -0.740740741 ± 4.927103944 |
The 9-Hole Pegboard Test evaluates one's upper extremity motor function. It is a timed test in which participants place 9 pegs in a pegboard and then remove them. Faster times indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| time (seconds) | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the 9-Hole Pegboard Test | -6.15 ± 10.86369404 | -5.242258065 ± 11.16955019 | -6.755 ± 11.38578962 |
The gait initiation test evaluates the phase between standing motionless and steady-state locomotion. This is a timed test in which participants are given a go signal and the time until first stride is recorded. Faster times indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| time (seconds) | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Gait Initiation Test | 5.810333333 ± 22.17604991 | 2.491 ± 22.48954996 | 2.282 ± 27.67356219 |
The stepping thresholds test evaluates a person's compensatory stepping thresholds. This is a test in which the floor surface is unexpectedly moved beneath a participant. The distance a participant moves their feet in order to compensate is recorded. The smaller displacement scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| mm displacement | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Stepping Thresholds Test | 0.616666667 ± 0.762067665 | 0.583333333 ± 0.732065257 | 0.603448276 ± 0.76039593 |
The quiet stance measure evaluates a person's postural control during quiet standing. This is a measure of sway distance. Lower scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline mm sway | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Quiet Stance Measure | -243.7980645 ± 746.4082743 | -50.747 ± 819.179683 | -65.52133333 ± 966.9356483 |
The Parkinson's Disease Quality of Life (PDQ-8) evaluates overall health status. It consists of eight questions regarding mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Participants choose answers on a scale ranging from never (0) to always (4) (minimum = 0, maximum = 32). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Parkinson's Disease Quality of Life | -5.756833333 ± 11.44863367 | -6.274655172 ± 12.96997528 | -7.924615385 ± 14.85058274 |
The Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" Short Form evaluates feelings that reflect a level of general satisfaction with life as well as a sense that life has purpose and meaning. Participants respond to questions on a 1-5 scale (minimum = 9, maximum = 45). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the the Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" Short Form | 1.321428571 ± 5.34064479 | 0.1 ± 5.652890625 | 0.04 ± 3.469870315 |
The Neuro-QOL Item Bank v1.1 "Satisfaction with Social Roles and Activities" short form short form evaluates one's satisfaction and discontentment with performing usual social roles and activities. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.1 "Satisfaction With Social Roles and Activities" Short Form | 2.142857143 ± 4.352217704 | 3.586206897 ± 4.917296305 | 1.24 ± 4.064890322 |
The Neuro-QOL Item Bank v2.0 ""Cognitive Function" short form evaluates mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v2.0 "Cognitive Function" Short Form | 3.821428571 ± 4.83853032 | 3.333333333 ± 5.234720513 | 2.72 ± 6.045108215 |
The Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" short form evaluates functioning of one's lower extremities. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" Short Form | 0.678571429 ± 4.172694053 | 1.333333333 ± 5.280630405 | -0.48 ± 5.393823628 |
The Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" short form evaluates functioning of one's upper extremity function in fine motor and ADL capabilities. Participants respond to questions on a 1-5 scale (minimum = 9, maximum = 45). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" Short Form | 2.392857143 ± 5.573344536 | 3.896551724 ± 6.635105918 | 1.76 ± 5.532329226 |
The Neuro-QOL Item Bank v1.0 "Stigma" short form evaluates one's sensitivity of illness-related stigma. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Stigma" Short Form | -2.107142857 ± 4.755809591 | -2.333333333 ± 6.143869012 | -1.76 ± 6.022734706 |
The Neuro-QOL Scale v1.0 "Communication" short form evaluates one's difficulty with communication. Participants respond to questions on a 1-5 scale (minimum = 5, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Neuro-QOL Scale v1.0 "Communication" Short Form | 0.535714286 ± 12.79028029 | 1.633333333 ± 10.9559725 | 2.6 ± 14.29743567 |
Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" short form evaluates one's confidence to manage/control symptoms of frustration, disappointment, anger, and other negative emotions. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" Short Form | -1.142857143 ± 7.158079019 | 0.133333333 ± 5.667410364 | -0.76 ± 7.44020609 |
The PROMIS v1.0 "Global Health" short form evaluates the individual's global health. This is a 10 question scale on which 9 of the questions are answered with a 1 - 5 score. The remaining item is answered with a 0 - 10 score. (minimum = 9, maximum = 55). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Global Health" Short Form | 1.5 ± 5.763872155 | 0.433333333 ± 4.546186984 | 0.375 ± 4.604463808 |
The (PROMIS) Scale v1.2 "Global Health" evaluates one's overall physical and mental health. This is a 10 item scale with scores ranging from 4-20. Higher scores indicate better overall health. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 "Global Health Mental Health Score" | 2.607142857 ± 5.983553297 | -0.5 ± 6.730015115 | 3.166666667 ± 7.590993901 |
The PROMIS v2.0 "Ability to Participate in Social Roles and Activities" short form evaluates one's perceived ability to perform one's usual social roles and activities. This is an 8 question measure and answers are given on a 1 - 5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Ability to Participate in Social Roles and Activities" Short Form | 1.230769231 ± 5.666093485 | 1.24137931 ± 5.717486788 | 2.333333333 ± 5.121707143 |
The PROMIS v1.0 "Emotional Distress - Anxiety" short form evaluates one's feelings of anxiety, such as fear and worry. This is a 7 item scale and participants answer with a 1 - 5 score for each item (minimum = 7, maximum = 35). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Anxiety" Short Form | -2.178571429 ± 5.192969403 | -0.7 ± 5.802199345 | -2.333333333 ± 6.598199139 |
The PROMIS v1.0 "Emotional Distress - Depression" short form evaluates one's feelings of negative mood and depression. This is an 8 item scale and participants answer with a 1 - 5 score for each item (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Depression" Short Form | -1.071428571 ± 4.126953602 | -0.533333333 ± 4.987801211 | -1.541666667 ± 7.052468989 |
The PROMIS v1.0 "Fatigue" short form evaluates one's range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. This is a 6 item scale and participants answer with a 1 - 5 score for each item (minimum = 6, maximum = 30). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Fatigue" Short Form | -3.25 ± 6.304760106 | -1.933333333 ± 6.766720457 | -2.173913043 ± 7.088096128 |
The PROMIS v2.0 "Physical Function" short form measures self-reported capability rather than actual performance of physical activities. This is a 10 item scale and participants answer with a 1 - 5 score for each item (minimum = 10, maximum = 50). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Physical Function" Short Form | 1.964285714 ± 3.666486287 | 1.724137931 ± 3.99013562 | 0.652173913 ± 3.926699929 |
The PROMIS v1.0 "Pain Interference" short form evaluates the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. This is a 6 item scale and participants answer with a 1 - 5 score for each item (minimum = 6, maximum = 30). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement | -1.75 ± 6.304760106 | -2.275862069 ± 7.372228543 | -2.818181818 ± 7.768289409 |
The PROMIS v1.0 "Sleep Disturbance" short form evaluates one's perceptions of sleep quality. This is an 8 item scale and participants answer with a 1 - 5 score for each item (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Sleep Disturbance" Short Form | -2.592592593 ± 7.781928075 | -3.965517241 ± 8.042222324 | -3.739130435 ± 4.673108672 |
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. On this test participants are asked to match pictures to a category and receive one point for each correct match (minimum = 0, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Dimensional Change Card Sort Score | 0.210526316 ± 14.11688881 | 0.473684211 ± 7.47862451 | 3 ± 7.874007874 |
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The Flanker Test is a test in which participants are asked to focus on a particular stimulus while inhibiting attention to another. An accuracy score is derived by calculating (Accuracy Score = 0.125 \* Number of Correct Responses) (minimum=0, maximum=5). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| accuracy score | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Flanker Test Score | 2.263157895 ± 8.15026997 | 3.526315789 ± 4.562752837 | 2.3125 ± 5.134442521 |
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The list sorting working memory test is a test in which lists of items are presented and participants are asked to recall items from the list in a particular order. Scoring is done based on the number of items correctly recalled and sequenced (minimum = 0, maximum = 26). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| change from baseline units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery List Sorting Working Memory Test Score | -0.947368421 ± 9.553787406 | 0.526315789 ± 11.15232124 | -1.3125 ± 10.2613758 |
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The oral reading recognition test is a test in which participants are asked to read and pronounce words as accurately as possible. Pronunciation is judged by the test administrator and a score is given to each response (minimum = 0, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| words/letters correctly pronounced | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Oral Reading Test Score | -1.578947368 ± 6.890539323 | -1.894736842 ± 5.867942445 | -3.25 ± 5.272570531 |
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The pattern comparison test is a test in which participants are presented with two pictures and are asked to discern whether they are he same or different. Correct answers are given one point for up to a maximum of 130 trials (minimum = 0, maximum = 130). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| units on a scale | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Pattern Comparison Test Score | 1.421052632 ± 11.19680406 | 3.526315789 ± 13.61114095 | 2.8125 ± 14.27920983 |
The picture sequencing test is a test of episodic memory in which participants are asked to recall increasingly lengthy series of illustrated objects and activities that are presented in a particular order on a computer screen. Participants are given credit for each adjacent pair of pictures they correctly place up to the maximum value for the sequence, which is one less than the sequence length (minimum = 0, maximum = 105). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| number of correct sequences identified | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Picture Sequencing Test Score | 1.842105263 ± 13.22146049 | 4.263157895 ± 10.09863635 | 2.875 ± 8.891006692 |
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The picture vocabulary test is a test in which participants are presented with an audio recording of a word and four photographic images on the computer screen and asked to select the picture that most closely matches the meaning of the word (minimum = 0, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
| number of correct matches | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Picture Vocabulary Test Score | -1.105263158 ± 5.205709866 | -0.578947368 ± 5.480427695 | -1.0625 ± 5.93822364 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Directional DBS Guided by Behavior | 0/30 (0%) | 3/31 (9.7%) | 2/31 (6.5%) |
| Omnidirectional DBS Guided by Behavior | 0/30 (0%) | 4/31 (12.9%) | 0/31 (0%) |
| Directional DBS Guided by Biomarkers | 0/30 (0%) | 0/31 (0%) | 0/31 (0%) |
| Event | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| SAE1Cardiac disorders | 0/31 | 1/31 | 0/31 |
| SAE2Surgical and medical procedures | 1/31 | 1/31 | 0/31 |
| SAE3Nervous system disorders | 0/31 | 1/31 | 0/31 |
| SAE4Psychiatric disorders | 1/31 | 0/31 | 0/31 |
| SAE5Product Issues | 1/31 | 1/31 | 0/31 |
| Event | Directional DBS Guided by Behavior | Omnidirectional DBS Guided by Behavior | Directional DBS Guided by Biomarkers |
|---|---|---|---|
| AE1Product Issues | 2/31 | 0/31 | 0/31 |
All 31 participants experienced all arms of the study.
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 26 |
| >=65 years | 5 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 58.85 ± 7.60 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 10 |
| Male | 21 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 28 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 31 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We will share data through the Data Archive BRAIN Initiative (DABI) data sharing consortium.
Supporting information: Clinical study report, Analytic code
Time frame: The data will be made available after analyses of the primary and secondary outcomes.
Access criteria: Users must set up an account on the DABI website to be able to access data.
Data sharing details ↗ · dabi.loni.usc.edu
Ran from Nov 2017 to primary completion in Aug 2022, 57 months.
Results were first posted in Apr 2024, 1 year 8 months after primary completion.
Of 1,296 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 57 months is above that.
Counting every sponsor, half of 1,369 studies reached it within 24 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →