New deep brain stimulation method for treating essential tremor
Coordinated Reset Deep Brain Stimulation for Essential Tremor
PHASE1 · University of Minnesota · NCT05897775
This study is testing a new deep brain stimulation method for people with essential tremor to see if it works better than the usual treatment for shaking in the arms and hands.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05897775 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel approach to deep brain stimulation (DBS) called coordinated reset DBS (CR-DBS) for patients with essential tremor. The study aims to assess the feasibility, safety, and short-term efficacy of CR-DBS in the thalamus, specifically targeting upper extremity tremors. Participants will undergo a pre-operative MRI and will be implanted with a rechargeable DBS system. The trial will compare the effects of CR-DBS with traditional high-frequency stimulation methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and over diagnosed with essential tremor who are eligible for deep brain stimulation.
Not a fit: Patients with significant neurological disorders, cognitive impairment, or those with a history of certain psychiatric diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients suffering from essential tremor.
How similar studies have performed: While traditional DBS has been widely studied, this novel coordinated reset approach is relatively untested, making it a potentially groundbreaking method.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Jing Wang, PhD — University of Minnesota
- Study coordinator: Jing Wang, PhD
- Email: wang3444@umn.edu
- Phone: (612) 626-6071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Essential Tremor, Upper Extremity Essential Tremor