NCT02535884

Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD)

Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD): A Prospective, Randomised, Controlled, International, Multi-centre Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to prove the efficacy and safety of pallidal DBS in HD patients and to show superiority of DBS on motor function in the stimulation group compared to stimulation-off group

Detailed description

In this study the efficacy and safety of pallidal Deep Brain Stimulation (DBS) in HD patients shall be investigated and superiority of DBS on motor function in the stimulation group compared to the stimulation-off group shall be shown. This study is a prospective, randomised, double blind, parallel group, sham-controlled, multi-centre trial. Patients in the stimulation group will be stimulated for three months while the stimulator in the sham-group will be turned off for three months. After three months the primary endpoint will be assessed. Afterwards the stimulator will be turned on in all patients.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DEVICE	ACTIVA® PC neurostimulator (Model 37601)	the stimulator in the stimulation group will be turned on after implantation of the device

Timeline

• Start date: 2014-07-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2015-08-31
• Last updated: 2022-01-21

Locations

12 sites across 4 countries: Austria, France, Germany, Switzerland