Nighttime-adaptive deep brain stimulation for essential tremor
Circadian Adaptive Deep Brain Stimulation in Essential Tremor
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 21 Years to 89 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06635811 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gainesville, Florida
- Norman Fixel Institute for Neurological Diseases — Gainesville, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Julia Gonzalez
- Email: Julia.Gonzalez@neurology.ufl.edu
- Phone: 352-733-3064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.