Coordinated Reset Deep Brain Stimulation for Essential Tremor

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

• Planned post-operative CT scan

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Jing Wang, PhD
wang3444@umn.edu
(612) 626-6071
Backup
Peter M Grund, BS
grund130@umn.edu
612-624-6434
Time Frame
Start Date: 2023-09-11
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 23
Treatments
Experimental: Coordinated Reset DBS Setting (CR-DBS)
Coordinated Reset DBS settings
Other: Clinically Optimized DBS Setting (T-DBS)
Traditional DBS settings
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov