Deep Brain Stimulation Clinical Trials

Clinical trials related to Deep Brain Stimulation Procedure

Circadian Adaptive Deep Brain Stimulation in Essential Tremor

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 89
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Norman Fixel Institute for Neurological Diseases
RECRUITING
Gainesville
Contact Information
Primary
Julia Gonzalez
Julia.Gonzalez@neurology.ufl.edu
352-733-3064
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2029-10
Participants
Target number of participants: 25
Treatments
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.
Sponsors
Leads: University of Florida

This content was sourced from clinicaltrials.gov