Actively Recruiting
Coordinated Reset Deep Brain Stimulation for Essential Tremor
Led by University of Minnesota · Updated on 2025-11-28
23
Participants Needed
1
Research Sites
276 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Coordinated Reset Deep Brain Stimulation for Essential Tremor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 the University of Minnesota IRB #1210M22183 protocol
- Planned post-operative CT scan
You will not qualify if you...
- History of musculoskeletal disorders that affect movement of the limbs or gait
- Other significant neurological disorder
- History of dementia or cognitive impairment preventing 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 months prior to implantation
- Suspicion of Parkinsonian tremor or features such as bradykinesia, rigidity, or instability
- Other significant medical disorder that could impede study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
J
Jing Wang, PhD
CONTACT
J
Johanna Caskey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NA
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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