RECRUITING Phase 1 ClinicalTrials.gov

Coordinated Reset Deep Brain Stimulation for Essential Tremor

Sponsor: University of Minnesota • ClinicalTrials.gov ID: NCT05897775

Registry updated: 2026-10-20

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Description

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 peak frequency of tremor related oscillatory activities in VIM (Phase I). The second aim is to compare the acute effects of thalamic CR-DBS to clinically optimized T-DBS (Phase II).

Interventions

Deep brain stimulation (Device)
Thalamic coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude, high frequency stimulation. Each participant will receive both the new intervention and the standard of care intervention, each for a week.

Eligibility criteria

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

Conditions

Essential Tremor Upper Extremity Essential Tremor

Locations

University of Minnesota — Minneapolis, Minnesota, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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