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RECRUITING
NCT06635811
NA

Circadian Adaptive DBS in Essential Tremor

Sponsor: University of Florida

View on ClinicalTrials.gov

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.

Official title: Circadian Adaptive Deep Brain Stimulation in Essential Tremor

Key Details

Gender

All

Age Range

21 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-05-01

Completion Date

2029-10

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

DEVICE

Circadian Adaptive DBS

DBS automatically turned off during sleep

DEVICE

Conventional DBS

Continous DBS

Locations (1)

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, United States