Investigating new brain stimulation methods for Essential Tremor
Physiology, Imaging and Modeling of Deep Brain Stimulation for Essential Tremor
This study is testing new ways to use brain stimulation for people with Essential Tremor to see if it can help reduce their symptoms safely without surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 2 sites (Gainesville, Florida and 1 other locations) |
| Trial ID | NCT03811405 on ClinicalTrials.gov |
What this trial studies
This project explores innovative ways to enhance deep brain stimulation (DBS) for patients with Essential Tremor (ET) by modifying existing devices. The study focuses on the safety and efficacy of alternative stimulation parameters, particularly active biphasic stimulation, without requiring invasive surgical procedures. By examining the physiological effects of these new stimulation techniques, the research aims to fill knowledge gaps regarding neuromodulation in human tremor. The hypothesis suggests that active biphasic stimulation may offer a broader therapeutic window and fewer adverse effects compared to traditional DBS.
Who should consider this trial
Good fit: Ideal candidates include individuals with existing unilateral or bilateral DBS for Essential Tremor who have experienced suboptimal tremor suppression.
Not a fit: Patients without a diagnosis of Essential Tremor will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with Essential Tremor, enhancing their quality of life.
How similar studies have performed: Other studies have shown promise in exploring alternative stimulation methods for DBS, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Existing unilateral or bilateral VIN DBS for ET, non-demented (MMSE\>24), and must have a documented suboptimal tremor suppression on two successive visits (compared to the baseline post-operative improvement at 6 months following ET DBS surgery). For bilateral cases, the most affected tremor side will be studied. Exclusion Criteria: * No diagnosis of Essential Tremor
Where this trial is running
Gainesville, Florida and 1 other locations
- UF Health at the University of Florida — Gainesville, Florida, United States (Recruiting)
- McKnight Brain Institute--Fixel Center for Neurological Diseases — Gainesville, Florida, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Leonardo B Almeida, MD — Univeristy of Florida
- Study coordinator: Leonardo B Almeida, MD
- Email: Leonardo.BritodeAlmeida@neurology.ufl.edu
- Phone: (352) 294-5400
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.