RecruitingNot ApplicableNCT06635811

Circadian Adaptive DBS in Essential Tremor

Circadian Adaptive Deep Brain Stimulation in Essential Tremor


Sponsor

University of Florida

Enrollment

25 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Circadian Adaptive DBS and a medical device called Conventional DBS for people with essential tremor, essential tremor (et), and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECircadian Adaptive DBS

DBS automatically turned off during sleep

DEVICEConventional DBS

Continous DBS


Locations(1)

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, United States

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NCT06635811


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