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Coordinated Reset Deep Brain Stimulation for Essential Tremor

RecruitingPhase 1Ages 21 Years - anyAllUniversity of Minnesota
NCT05897775 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Deep brain stimulation (DBS) is a surgical procedure for the treatment of Essential Tremor (ET). A novel approach to current DBS approaches is called coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS that uses continuous high amplitude, high frequency stimulation. This study will evaluate the feasibility, safety and short-term efficacy of thalamic CR-DBS in upper extremity ET. The goal of this study is to evaluate the safety and short-term efficacy of thalamic CR- DBS in ET, including the acute (during CR-DBS) and carryover (following DBS cessation) effects, and compare these to those induced by clinically optimized T-DBS. To achieve our goal, a low-risk, two-phase clinical study will be conducted in patients with upper extremity (UE) ET. The first aim is to identify the spatial location and pe

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of essential tremor (ET) * Age of 21 or over * Will be or has been implanted with Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system * 7 Tesla (7T) MRI pre-operative scan under Noam Harel PhD's Center for Magnetic Research (University of Minnesota IRB #1210M22183) protocol "Imaging of DBS targets at 7T MRI". Participants who do not agree to get the 7T MRI under IRB #1210M22183 can still participate in this protocol. Alternatively, their clinical MRI scans will be used. * Planned or completed post-operative CT scan Exclusion Criteria: * History of musculoskeletal disorders that affect movement of the limbs or gait * Pregnant women * Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability * Other significant medical disorder (e.g., depression, dementia, or cognitive impairment) that could impede study participation
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What it tests

  • Deep brain stimulation
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Where

1 site
University of Minnesota
Minneapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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