Recruiting
Phase 1

Coordinated Reset DBS

Sponsor:

University of Minnesota

Code:

NCT05897775

Conditions

Essential Tremor

Upper Extremity Essential Tremor

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Deep brain stimulation

Study Details

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 ID

NCT05897775

Start date

Sep 11, 2023

Status verified date

Jun, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

23 participants

Anticipated

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Coordinated Reset DBS Setting (CR-DBS)

Coordinated Reset DBS settings

other: Clinically Optimized DBS Setting (T-DBS)

Traditional DBS settings

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jing Wang, PhD

(612) 626-6071wang3444@umn.edu

Selam Woldegerima

(763) 347-1287wolde183@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Selam Woldegerima

763-347-1287wolde183@umn.edu

Jing Wang, PhD

(612) 626-6071wang3444@umn.edu

Principal Investigator:

Jing Wang, PhD

More Information

Sponsor

University of Minnesota

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-06-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.