NCT04260971

Cyclic Deep Brain Stimulation in Essential Tremor

Cyclic Versus Continuous Deep Brain Stimulation in Essential Tremor

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	Abbott St Jude Medical Infinity 7 neurostimulator	The stimulator has the capability to deliver both continuous and cyclical modes of stimulation which is being investigated in this study

Timeline

• Start date: 2020-02-25
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-02-07
• Last updated: 2021-09-02

Locations

1 site across 1 country: United Kingdom