Coordinated Reset Deep Brain Stimulation for Essential Tremor

NCT05897775 | Recruiting Phase 1 FDA Device

• 1 other identifier: NEUR-2023-31652
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Tremor Research Group Essential Tremor Rating Scale (TETRAS)

  TETRAS is a rating scale introduced by the Tremor Research Group which has undergone extensive performance evaluations7. The TETRAS Activities of Daily Living Subscale (TETRAS-ADL) rates tremor's impact on activities of daily living, using 12 test items with each item scored from 0-4 (increasing with severity). The TETRAS-ADL total score range is 0-48. The TETRAS performance subscale (TETRAS-P) consists of 16 scored items designed to measure essential tremor of the head, face, voice, upper extremity, lower extremity and trunk, with each item scored from 0-4 (increasing with severity). Specific amplitude measurements are used to guide the ratings for each item. Tasks of spiral drawing, handwriting and object holding are included. The TETRAS-P total score range is 0-64. The total TETRAS score, including both TETRAS-ADL and TETRAS-P, ranges from 0 to 112.

  4 months

Secondary Outcomes (8)

• Instrumented Tremor Measurement

  4 months

• Bain Tremor Disability Scale (BTDS)

  4 months

• Quality of Life in Essential Tremor (QUEST)

  4 months

• Quantitative Archimedes Spirals

  4 months

• Dot Approximation Task

  4 months

Study Arms (2)

Coordinated Reset DBS Setting (CR-DBS)

EXPERIMENTAL

Coordinated Reset DBS settings

Device: Deep brain stimulation

Clinically Optimized DBS Setting (T-DBS)

OTHER

Traditional DBS settings

Device: Deep brain stimulation

Interventions

Deep brain stimulation 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); Coordinated Reset DBS Setting (CR-DBS)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jing Wang, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Wang, PhD

CONTACT

(612) 626-6071; wang3444@umn.edu

Johanna Caskey

CONTACT

(763) 353-9470; caske039@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will be blinded to the order of interventions they receive. The investigators assessing the severity of tremor and side effects through videos will also be blinded to the intervention condition.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will receive both the new intervention which is a new stimulation pattern and the standard of care intervention, each for a week.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 9, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

US (1)