RECRUITING

Coordinated Reset Deep Brain Stimulation for Essential Tremor

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Coordinated Reset Deep Brain Stimulation for Essential Tremor

Quick Facts

Study Start:2023-09-11
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05897775

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of Essential Tremor (ET)
  2. * Age of 21 or over
  3. * Will be implanted with Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
  4. * 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"
  5. * Planned post-operative CT scan
  1. * History of musculoskeletal disorders that affect movement of the limbs or gait
  2. * Other significant neurological disorder
  3. * History of dementia or cognitive impairment (Mini-Mental Score \< 26)
  4. * Significant psychiatric disease
  5. * On medication that could cause tremor
  6. * Prior brain surgery
  7. * Pregnant women
  8. * Evidence of non-ET central nervous system disease or injury for at least three (3) months prior to implantation
  9. * Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability
  10. * Other significant medical disorder that could impede study participation

Contacts and Locations

Study Contact

Jing Wang, PhD
CONTACT
(612) 626-6071
wang3444@umn.edu
Peter M Grund, BS
CONTACT
612-624-6434
grund130@umn.edu

Principal Investigator

Jing Wang, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Jing Wang, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-11
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2023-09-11
Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Essential Tremor
  • Upper Extremity Essential Tremor