Coordinated Reset Deep Brain Stimulation for Essential Tremor

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05897775
Phase
PHASE1
Status
Recruiting
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Conditions

  • Essential Tremor
  • Upper Extremity Essential Tremor

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Sep 11, 2023
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Coordinated Reset DBS Setting (CR-DBS)
    Coordinated Reset DBS settings
  • Other: Clinically Optimized DBS Setting (T-DBS)
    Traditional DBS settings

Primary Outcome Measure

Tremor Research Group Essential Tremor Rating Scale (TETRAS) [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Selam Woldegerima
[email protected]
763-347-1287
Jing Wang, PhD
[email protected]
(612) 626-6071
Jing Wang, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
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