An interventional study of Circadian Adaptive DBS and Conventional DBS in Essential Tremor, Essential Tremor (ET) and Essential Tremor, Movement Disorders, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 21 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
Deep brain stimulation (DBS) of the thalamus is an effective treatment for medically refractory essential tremor (ET). DBS involves delivering continuous stimulation to the brain through electrodes permanently implanted in the thalamus. Despite proven effectiveness, the long-term benefit of DBS can wane over time (habituation) and side effects, including paresthesia and dysarthria, often limit the amplitude of the stimulation, resulting in suboptimal control of tremor. In clinical practice, many groups advise patients to switch their devices off at night to avoid habituation and reduce side effects. However, manually turning off the device at night can result in uncontrolled tremor when the patient moves at night.
This study aims to develop an algorithm that automatically turns off stimulation when a patient is asleep, based on circadian brain signals. Turning off stimulation could potentially improve the therapy by limiting adverse effects, increasing efficacy, reducing the risk of habituation, and prolonging battery life. This study will evaluate the feasibility, safety, and tolerability of circadian adaptive DBS.
This single-center study will investigate the feasibility of developing an adaptive Deep brain stimulation (aDBS) strategy using thalamic circadian rhythm as a control signal. It will evaluate the safety and tolerability of aDBS compared to conventional DBS (cDBS) in a double-blinded cross-over design.
This study will recruit 25 Essential Tremor (ET) patients implanted with the bidirectional neural interface, Medtronic Percept PC (FDA approved), attached to DBS directional lead(s) (Sensight) implanted unilaterally or bilaterally in the ventral intermediate nucleus (VIM) and who are receiving adequate control of their tremor with VIM DBS.
First, the brain signal will be recorded for 1 month to identify circadian fluctuations that may be used to identify the period of sleep. Second, for each patient, an aDBS algorithm based on individualized brain activity will be developed and tested for 2 weeks in a double-blinded cross-over design comparing aDBS and cDBS. Third, at the end of this 4-week trial, patients who preferred aDBS will have the opportunity to stay on aDBS for 6 months, allowing to assess the long-term tolerability of the aDBS.
Each patient enrolled in this study will participate in 7 study visits over 8 months during which chronic brain recordings and aDBS will be set up. Symptoms and stimulation-induced side effects will be assessed by clinicians during these visits. Self-rating scales and wearable will be provided to track tremor, sleep, and movement at home.
272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.
This study's planned enrollment of 25 is close to the median of 25 across 189 interventional studies indexed under Essential Tremor.
Browse Essential Tremor studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will initially have their DBS programmed to automatically turn off during sleep for 2 weeks. Then, they will transition to continuous stimulation for another 2 weeks.
Device: Circadian Adaptive DBS · Device: Conventional DBS
Participants will initially have their DBS programmed with continuous stimulation for 2 weeks. Then, they will transition to having their DBS automatically turned off during sleep for another 2 weeks.
Device: Circadian Adaptive DBS · Device: Conventional DBS
DBS automatically turned off during sleep
Continous DBS
Presence of thalamic circadian rhythm
Thalamic circadian rhythm is defined as a significant difference in day vs night brain activity. It can be used to set up adaptive DBS.
Time frame: Baseline (first month of study participation)
Incidence of stimulation-induced adverse events with aDBS compared to cDBS
Adverse events are monitored the entire time subject is enrolled in study. Stimulation-induced adverse events during the double-blind crossover is a primary endpoint.
Time frame: Double-blind crossover period (second month of study participation)
Patient's quality of life as assessed by the Quality of Life in Essential Tremor Questionnaire (QUEST), adapted for a 2-week assessment
The QUEST is designed to evaluate the impact of essential tremor on daily functioning and well-being. The total score ranges from 0 to 120, with higher scores indicating worse quality of life.
Time frame: From enrollment to the end of study (8 months)
The Tremor Research Group Essential Tremor Rating Scale (TETRAS) Activities of Daily Living Subscale
The TETRAS Activities of Daily Living Subscale will assess the ability to perform daily tasks. The total score ranges from 0 to 48, with higher scores indicating greater difficulty in performing tasks.
Time frame: From enrollment to the end of study (8 months)
Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI), adapted for a 2-week assessment
The PSQI is used to assess the quality of sleep. PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Each of the seven components of the PSQI is scored from 0 to 3, with 3 indicating the greatest dysfunction.
Time frame: From enrollment to the end of study (8 months)
Patient's cognition as assessed by the Montreal Cognitive Assessment 5-Minute Protocol (Mini MoCA)
The Mini MoCA will be used to evaluate cognitive function in patients. It assesses short-term memory, executive function, verbal fluency, attention, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive performance.
Time frame: From enrollment to the end of study (8 months)
Patient's mood as assessed by the Beck Depression Inventory-II (BDI-II), adapted for a 2-week assessment
The BDI-II will be used to assess depressive symptoms in patients. The questionnaire consists of 21 items, each rated on a scale from 0 to 3. Total scores range from 0 to 63, with higher scores indicating more severe depression. Scores are categorized as minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63).
Time frame: From enrollment to the end of study (8 months)
Patient's impression as assessed by the Patient Global Impression of Change Scale (PGI-C)
The PGI-C will be used to evaluate the patient's perception of improvement or worsening over time. The PGI-C is rated on a 7-point Likert scale, ranging from 1 (very much improved) to 7 (very much worse). Lower scores indicate better-perceived improvement, while higher scores reflect deterioration.
Time frame: From enrollment to the end of study (8 months)
Patient's self-report of side effects, tremor severity, and sleep
At each study visit symptoms are assessed using our Custom Symptom Questionnaire (CSQ). Additionally, during the double-blind crossover period, side effects, tremor severity, and sleep is assessed daily using our Daily Assessment scale.
Time frame: From enrollment to the end of study (8 months)
Presence/severity of tremor tracked with wearable device
Subjects will be given a wearable device, a Fitbit watch, for objective assessment of tremor.
Time frame: From enrollment to the end of double-blind crossover period (first two months of study)
Battery drainage/Stimulation energy use as assessed by Total Electrical Energy Delivered (TEED)
The TEED will be calculated and compared for both aDBS and cDBS over a 2-week period. TEED is measured in millijoules (mJ), and lower values indicate lower energy consumption.
Time frame: From enrollment to the end of study (8 months)
Started May 2025 (actual). Primary completion is estimated for Oct 2028, 41 months after the start.
Of 77 non-industry interventional studies with no phase under Essential Tremor, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 26. This study's planned 41 months is below that.
Counting every sponsor, half of 95 studies reached it within 45 months; a quarter within 19 and three quarters within 93.
How these figures are worked out, and which studies are left out of them.
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