Coordinated Reset Deep Brain Stimulation for Essential Tremor

NCT ID: NCT05897775

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2028-12-31

Brief 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).

Conditions

Essential Tremor; Upper Extremity Essential Tremor

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Coordinated Reset DBS Setting (CR-DBS)

Coordinated Reset DBS settings

Group Type: EXPERIMENTAL

Deep brain stimulation

Intervention Type: 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.

Clinically Optimized DBS Setting (T-DBS)

Traditional DBS settings

Group Type: OTHER

Deep brain stimulation

Intervention Type: 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.

Interventions

Deep brain stimulation

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.

Intervention Type: DEVICE

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"
• Planned post-operative CT scan

Exclusion Criteria

• History of musculoskeletal disorders that affect movement of the limbs or gait
• Other significant neurological disorder
• History of dementia or cognitive impairment that precludes them from getting DBS surgery
• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jing Wang, PhD

Role: CONTACT

wang3444@umn.edu

(612) 626-6071

Johanna Caskey

Role: CONTACT

caske039@umn.edu

(763) 353-9470

Facility Contacts

Johanna Caskey

Role: primary

caske039@umn.edu

763-353-9470

Jing Wang, PhD

Role: backup

wang3444@umn.edu

(612) 626-6071

Other Identifiers

NEUR-2023-31652

Identifier Type: -

Identifier Source: org_study_id