Recruiting

Circadian Adaptive DBS

Sponsor:

University of Florida

Code:

NCT06635811

Conditions

Essential Tremor

Essential Tremor (ET)

Essential Tremor, Movement Disorders

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Circadian Adaptive DBS

Conventional DBS

Study Details

Brief summary:

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.

Conditions

Essential Tremor

Essential Tremor (ET)

Essential Tremor, Movement Disorders

Study ID

NCT06635811

Start date

May 1, 2025

Status verified date

Jul, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adaptive DBS, Then Conventional DBS

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.

experimental: Conventional DBS, then Adaptive 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.

Interventions

Circadian Adaptive DBS

DBS automatically turned off during sleep

Conventional DBS

Continous DBS

Primary outcome measure

  • Presence of thalamic circadian rhythm [ Time Frame: Baseline (first month of study participation) ]
  • Incidence of stimulation-induced adverse events with aDBS compared to cDBS [ Time Frame: Double-blind crossover period (second month of study participation) ]

Central Contacts and Locations

Central contacts

Julia C Gonzalez, BA

(352) 265-0111Julia.Gonzalez@neurology.ufl.edu

Locations

Norman Fixel Institute for Neurological Diseases

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Julia C Gonzalez, BA

352-265-0111Julia.Gonzalez@neurology.ufl.edu

Principal Investigator:

Coralie de Hemptinne, PhD

More Information

Sponsor

University of Florida

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Deep Brain Stimulation
  • DBS
  • Adaptive DBS
  • Adaptive Deep Brain Stimulation
  • Circadian

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.