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Clinical Trial Summary

The aim of the study is to prove the efficacy and safety of cyclical deep brain stimulation (DBS) in patients with essential tremor, and demonstrate non-inferiority of cyclical DBS on tremor control when compared to continuous stimulation.


Clinical Trial Description

This study is a prospective, randomized, double-blind cross-over trials. Patients will be randomized into two groups in a cross-over fashion to have either continuous or cyclical stimulation for a total of three months. Following this, the trial will be unblinded and open-label follow up will continue for another nine months. Device use as per standard practice continues after the end of the trial. If the hypothesis is proven correct, this will provide proof of concept that cyclical stimulation for the treatment of essential tremor results in improved battery life, reduced number of operations for battery changes, reduction in stimulation side-effects and enhancing quality of life. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04260971
Study type Interventional
Source King's College Hospital NHS Trust
Contact Kantharuby Tambirajoo, MD
Phone 00442032991906
Email kantharuby.tambirajoo@nhs.net
Status Recruiting
Phase N/A
Start date February 25, 2020
Completion date December 31, 2022

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