Coordinated Reset Deep Brain Stimulation for Essential Tremor

Launched by UNIVERSITY OF MINNESOTA · Jun 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to deep brain stimulation (DBS) for patients with Essential Tremor (ET), a condition that causes uncontrollable shaking, particularly in the hands. The trial is testing a method called coordinated reset DBS (CR-DBS), which uses different patterns of stimulation at lower levels than traditional DBS. The goal is to see if this new method is safe and effective in reducing tremors in the upper body. Researchers will compare the effects of CR-DBS to the standard DBS treatment to understand how well it works both during the treatment and after it has stopped.

To participate in this study, you need to be at least 21 years old and diagnosed with Essential Tremor. You should also be eligible for a specific deep brain stimulation device. However, there are some exclusions—like having other major neurological disorders or significant psychiatric issues—that might prevent you from joining. If you participate, you can expect to undergo scans and receive either the new treatment or the standard treatment to help researchers learn more about the best ways to manage Essential Tremor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of Essential Tremor (ET)
• • Age of 21 or over
• • Will be 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 (Mini-Mental Score \< 26)
• • 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