Nighttime-adaptive deep brain stimulation for essential tremor
Official title: Circadian Adaptive Deep Brain Stimulation in Essential Tremor
Run by University of Florida · NCT06635811 · Data updated 2026-11-12
We will test whether using each patient’s thalamic sleep-related brain signals to automatically turn DBS off at night can reduce side effects while keeping tremor under control in people with essential tremor who already have Medtronic Percept implants.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 89 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | October 2028 |
| Study ends | October 2029 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT06635811 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (21–89) with essential tremor who have unilateral or bilateral VIM DBS leads attached to a Medtronic Percept PC and who achieve at least a 30% tremor improvement with their current DBS settings.
✕Probably not a fit
Patients without a Percept PC device, those whose thalamic signals do not show clear circadian modulation, or those whose tremor is not adequately controlled by their current DBS are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, double-blind crossover study will enroll 25 patients with essential tremor who have VIM leads connected to a Medtronic Percept PC. Researchers will record chronic thalamic signals for one month to identify individual circadian patterns, then create a personalized algorithm that turns stimulation off during sleep. Each patient will complete a two-week double-blind crossover comparing circadian-adaptive DBS (aDBS) to conventional continuous DBS, with clinicians rating symptoms and stimulation-induced side effects. Patients who prefer aDBS may continue it for six months to track longer-term tolerability using clinician scales, self-reports, and wearable sensors.
Why it matters
Potential benefit: If successful, the approach could reduce nighttime stimulation-related side effects and habituation, improving overall tremor control and sleep quality.
How similar studies have gone: Adaptive DBS using movement or neural biomarkers has shown promise in other work, but using thalamic circadian rhythms to automatically switch stimulation at night is a novel and relatively untested approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Essential Tremor confirmed by a Movement Disorders specialist following established criteria recommended by the Movement Disorders Society * Patients implanted with unilateral or bilateral VIM DBS leads attached to the Medtronic Percept DBS device for the treatment of Essential Tremor * Patients with clinical benefit of DBS as defined by a 30% improvement on the TRS or TETRAS at least 3 months after DBS implantation * DBS programmed in a monopolar configuration allowing chronic brain sensing (C+1- or C+2- in ring mode or any direction) * Be between 21 and 89 years old * Ability to give informed consent for the study Exclusion Criteria: * Inability to comply with the study protocol * Pregnancy: all women of childbearing potential will have a negative urine pregnancy test prior to undergoing the study * Current active suicidal ideation (Yes to #2-5 on C-SSRS) * Any personality or mood symptoms that study personnel believe will interfere with study requirements
Where it's running
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Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, United States Recruiting
Study contacts
- Study coordinator: Julia C Gonzalez, BA
- Email: Julia.Gonzalez@neurology.ufl.edu
- Phone: (352) 265-0111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.