Circadian Adaptive DBS in Essential Tremor

NCT06635811 | Recruiting DMC FDA Device

• 1 other identifier: IRB202400652
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

deep brain stimulation; adaptive DBS

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Double-blind crossover period (second month of study participation)

Secondary Outcomes (9)

• Patient's quality of life as assessed by the Quality of Life in Essential Tremor Questionnaire (QUEST), adapted for a 2-week assessment

  From enrollment to the end of study (8 months)

• The Tremor Research Group Essential Tremor Rating Scale (TETRAS) Activities of Daily Living Subscale

  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

  From enrollment to the end of study (8 months)

• Patient's cognition as assessed by the Montreal Cognitive Assessment 5-Minute Protocol (Mini MoCA)

  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

  From enrollment to the end of study (8 months)

Study Arms (2)

Adaptive DBS, Then Conventional DBS

EXPERIMENTAL

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

Conventional DBS, then Adaptive DBS

EXPERIMENTAL

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

Interventions

Circadian Adaptive DBS DEVICE

DBS automatically turned off during sleep

Adaptive DBS, Then Conventional DBS; Conventional DBS, then Adaptive DBS

Conventional DBS DEVICE

Continous DBS

Adaptive DBS, Then Conventional DBS; Conventional DBS, then Adaptive DBS

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Julia Gonzalez

CONTACT

352-733-3064; Julia.Gonzalez@neurology.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: October 10, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)