Coordinated Reset Deep Brain Stimulation for Essential Tremor

This study is testing a new way to use Deep Brain Stimulation (DBS) called coordinated reset DBS (CR-DBS) for people with Essential Tremor (ET) that affects their upper body. CR-DBS uses different patterns of stimulation at lower currents, which might be better than traditional DBS. The study will look at how safe and effective CR-DBS is in the short term, and compare it to traditional DBS. To join, you must be at least 21 years old, have an Essential Tremor diagnosis, and either have or be getting a specific Boston Scientific DBS system. You also need to have certain MRI and CT scans. The main goal is to see how much CR-DBS improves tremor symptoms after 4 months.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 23 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring tremor improvement is at 4 months.

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NCT05897775

Coordinated Reset Deep Brain Stimulation for Essential Tremor

Recruiting
PHASE1Ages 21+InterventionalTreatment
University of Minnesota
~23 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Deep brain stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tremor Research Group Essential Tremor Rating Scale (TETRAS)
Measured over 4 months
Essential Tremor
Upper Extremity Essential Tremor
1 sites across 1 states
Minnesota1
  • Jing Wang, PhD · PRINCIPAL_INVESTIGATOR · University of Minnesota

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Eligibility criteria

Inclusion

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

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
  • Tremor Research Group Essential Tremor Rating Scale (TETRAS)4 months

    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.