Circadian Adaptive DBS in Essential Tremor

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06635811
Status
Recruiting
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Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
21 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Circadian Adaptive DBS — DEVICE
    DBS automatically turned off during sleep
  • Conventional DBS — DEVICE
    Continous DBS

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Dec 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Presence of thalamic circadian rhythm [ Time Frame: Baseline (first month of study participation) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Norman Fixel Institute for Neurological DiseasesGainesvilleFlorida32608
Research Assistant
[email protected]
352-733-3048
Coralie de Hemptinne, PhD (PRINCIPAL_INVESTIGATOR)

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Norman Fixel Institute for Neurological Diseases· Gainesville, FL

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