Coordinated Reset Deep Brain Stimulation for Essential Tremor

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).

Conditions

Essential Tremor, Upper Extremity Essential Tremor

Study Overview

Study Details

Study overview

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).

Coordinated Reset Deep Brain Stimulation for Essential Tremor

Coordinated Reset Deep Brain Stimulation for Essential Tremor

Condition
Essential Tremor
Intervention / Treatment

-

Contacts and Locations

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of Essential Tremor (ET)
  • * Age of 21 or over
  • * Will be 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
  • * History of musculoskeletal disorders that affect movement of the limbs or gait
  • * Other significant neurological disorder
  • * History of dementia or cognitive impairment (Mini-Mental Score \< 26)
  • * Significant psychiatric disease
  • * On medication that could cause tremor
  • * Prior brain surgery
  • * Pregnant women
  • * Evidence of non-ET central nervous system disease or injury for at least three (3) months prior to implantation
  • * Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability
  • * Other significant medical disorder that could impede study participation

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Minnesota,

Jing Wang, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2028-06-30