An interventional study of Deep Brain Stimulation (DBS) of the Motor Thalamus in Traumatic Brain Injury, Stroke and Brain Disease, sponsored by Jorge Gonzalez-Martinez. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Jorge Gonzalez-Martinez · Not applicable, Interventional, and Basic science
This study aims to recruit patients already implanted with Deep Brain Stimulation (DBS) for movement disorders to complete tasks assessing parameters of motor output, speech, and swallowing functions, both with and without stimulation. DBS parameters would be adjusted prior to motor testing. Patients would then participate in multiple sessions performing contralateral upper extremity movement tasks measuring movement speed, grip strength, and strength modulation, facial movement, swallowing, and speech tasks.
The study is designed to assess the assistive effects of DBS (i.e., immediate effects when the stimulation is turned ON) and obtain preliminary evidence for therapeutic effects (i.e., long-lasting effects with stimulation OFF). Researchers will 1) quantify the ability to recruit facial and oropharyngeal muscles with electrical stimulation of the motor thalamus in patients with DBS for movement disorders, 2) quantify the ability to recruit arm and hand muscles with electrical stimulation of the motor thalamus in patients with DBS, and 3) verify if the delivery of DBS has effects on the central nervous system with clinical measures.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 60 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Jorge Gonzalez-Martinez is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with deep brain stimulation device implanted in the motor thalamus for movement disorders treatment who also sustain speech, swallowing, and motor deficits.
Device: Deep Brain Stimulation (DBS) of the Motor Thalamus
The investigators aim to include healthy control subjects who will complete the language and upper-limb tasks. The healthy subjects will not undergo any surgical procedures.
All participants enrolled will undergo stimulation parameters tuning of deep brain stimulation electrode leads. All subjects will participate in a series of experiments to evaluate the stimulation effects on movement of face and upper extremities, swallowing, and speech abilities.
Upper Limb Motor Function - Hand Dexterity
The investigators will use the Box and Blocks Test (unit counts) and Brinkmann Test (unit counts) to measure hand dexterity. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in hand dexterity as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Time frame: 2 years
Upper Limb Motor Function - Grip Strength
The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure grip strength (Newton). These tests will combine weight and height into a single BMI measurement in kg/m\^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in grip strength as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Time frame: 2 years
Upper Limb Motor Function - Velocity
The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure velocity (Newton per millisecond). These tests will combine weight and height into a single BMI measurement in kg/m\^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in velocity as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Time frame: 2 years
Upper Limb Motor Function - Strength Modulation
The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure strength modulation (Newton). These tests will combine weight and height into a single BMI measurement in kg/m\^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in modulation as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Time frame: 2 years
Facial Muscle Motor Function
The investigators will use electromyography (EMG) testing to measure muscle strength and range of motion produced by the subject during isometric facial movements (e.g. smile, tongue out, puckered lips, and open-close mouth), measured in by calculation of Area-Under-the-Curve with units of uV\^2/ms. These tests will combine weight and height into a single BMI measurement in kg/m\^2. Based on the preliminary data, the investigators will consider the number of participants with an increase of 50% in ROM as a minimally acceptable improvement in muscle strength.
Time frame: 2 years
Swallowing Function
The investigators will use the modified barium swallow study (MBSS) to assess oropharyngeal swallow functions. This is a performance evaluation scale, that consist of 17 items with varying scales. The total score ranges from 0 to 55, where a higher score means a better outcome. Based on the preliminary data, the investigators will consider the number of participants with an increase of 1 point in at least 50% of the items of the Modified Barium Swallow Impairment Profile as a minimally acceptable improvement in swallow functions.
Time frame: 2 years
Speech Intelligibility
The investigators will use the Assessment of Intelligibility of Dysarthric Speech (AIDS) to assess the quality of communication and intelligibility of speech at both word- and sentence-level. Intelligibility is calculated as the percentage of words correctly identified in the single-word task, and as the percentage of correctly transcribed words and speech rate (in words per minute) in the sentence task. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 5% correctly transcribed to be minimally acceptable.
Time frame: 2 years
Dexterity of Articulation AMRs
The investigators will measure dexterity of articulation by alternating motion rates (AMRs) of the repetitive plosive sound (pah, tah, and kah). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Time frame: 2 years
Dexterity of Articulation SMRs
The investigators will measure dexterity of articulation by sequential motion rates (SMRs) of the repetitive plosive sound (pah, tah, and kah). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Time frame: 2 years
Oral Motor Functions
The investigators will use the 2nd Edition Frenchay Dysarthria Assessment (FDA-2) to measure patterns of oral motor functions, with a particular focus on the following subsections: Respiration, Lips, Palate, Laryngeal, and Tongue. Each subsection is rated on a scale from "a" to "e", where "a" means normal for age, and "e" means unable to undertake task/movement/sound. So a score closer to "a" means a better outcome. Based on the preliminary data, the investigators will consider the number of participants with an improvement in severity level (e.g., from considerable to moderate severity, or a score of D to C) to be minimally acceptable.
Time frame: 2 years
Respiration Capacity - Total Exhaled Volume
The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on the forced vital capacity (FVC). The FVC is the total volume of air that can be forcefully exhaled after a maximal inhalation and this will be measured in liters (L). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.
Time frame: 2 years
Respiration Capacity - Volume Exhaled
The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on the volume exhaled in the first second (FEV1). The FEV1 is the volume of air exhaled in the first second of a forced exhalation and this will be measured in liters (L). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.
Time frame: 2 years
Respiration Capacity - FEV1/FVC Ratio
The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC). The ratio is expressed as a unitless percentage. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.
Time frame: 2 years
Oral Motor Strength
The investigators will use the Iowa Performance Instrument (IOPI) to measure motor strength of tongue and lip using maximum force and endurance. IOPI instrument measures force applied from oral cavity by kPa. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.
Time frame: 2 years
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification, may be shared with other researchers for the purpose of data analysis and collaboration.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will become available at the end of the trial upon publication of the first manuscript. Estimation is 7 years from enrollment of the first participant.
Access criteria: Data must be directly requested from the PI and will be shared upon completion of the necessary data-sharing agreement to protect confidential patient information.
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Jorge Gonzalez-Martinez