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Circadian Adaptive DBS for Essential Tremor

This study is looking at a new way to use Deep Brain Stimulation (DBS) for Essential Tremor, called Circadian Adaptive DBS. Currently, many people with DBS turn off their device at night to avoid side effects and the treatment becoming less effective over time. This new approach would automatically turn off your DBS device during sleep, based on your brain's natural rhythms. The study will compare this automatic method to the usual continuous DBS. We want to see if Circadian Adaptive DBS is safe and well-tolerated, and if it can help reduce side effects or improve long-term tremor control. You may be able to join if you are 21 to 89 years old, have Essential Tremor, and already have a Medtronic Percept DBS device implanted that is helping your tremor. The study aims to enroll 25 participants, but its current recruitment status is unclear.

Study design
This study is an interventional study with 25 participants, comparing Circadian Adaptive DBS to Conventional DBS in a double-blinded crossover design.
What's involved
You would participate in 7 study visits over 8 months, which will involve setting up brain recordings and the adaptive DBS.
Compensation
Not stated in the trial record.
Follow-up
Participants who prefer Circadian Adaptive DBS will have the opportunity to stay on it for 6 months after the initial 4-week trial period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06635811

Circadian Adaptive DBS in Essential Tremor

Recruiting
NAAges 21–89InterventionalTreatment
University of Florida
~25 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Circadian Adaptive DBSConventional DBS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Presence of thalamic circadian rhythm
Measured over Baseline (first month of study participation)
+1 more outcome measured

Conditions

Essential Tremor
Essential Tremor (ET)
Essential Tremor, Movement Disorders

Explore related trials

Essential Tremor

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Julia C Gonzalez, BA
[email protected]
(352) 265-0111 · ext. 32495
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Presence of thalamic circadian rhythmBaseline (first month of study participation)

    Thalamic circadian rhythm is defined as a significant difference in day vs night brain activity. It can be used to set up adaptive DBS.

  • Incidence of stimulation-induced adverse events with aDBS compared to cDBSDouble-blind crossover period (second month of study participation)

    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.