Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-05-01
2029-10-31
Brief Summary
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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.
Detailed Description
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This study will recruit 25 Essential Tremor (ET) patients implanted with the bidirectional neural interface, Medtronic Percept PC (FDA approved), attached to DBS directional lead(s) (Sensight) implanted unilaterally or bilaterally in the ventral intermediate nucleus (VIM) and who are receiving adequate control of their tremor with VIM DBS.
First, the brain signal will be recorded for 1 month to identify circadian fluctuations that may be used to identify the period of sleep. Second, for each patient, an aDBS algorithm based on individualized brain activity will be developed and tested for 2 weeks in a double-blinded cross-over design comparing aDBS and cDBS. Third, at the end of this 4-week trial, patients who preferred aDBS will have the opportunity to stay on aDBS for 6 months, allowing to assess the long-term tolerability of the aDBS.
Each patient enrolled in this study will participate in 7 study visits over 8 months during which chronic brain recordings and aDBS will be set up. Symptoms and stimulation-induced side effects will be assessed by clinicians during these visits. Self-rating scales and wearable will be provided to track tremor, sleep, and movement at home.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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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.
Circadian Adaptive DBS
DBS automatically turned off during sleep
Conventional DBS
Continous DBS
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.
Circadian Adaptive DBS
DBS automatically turned off during sleep
Conventional DBS
Continous DBS
Interventions
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Circadian Adaptive DBS
DBS automatically turned off during sleep
Conventional DBS
Continous DBS
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
21 Years
89 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Locations
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Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Research Assistant
Role: primary
Other Identifiers
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IRB202400652
Identifier Type: -
Identifier Source: org_study_id