Comparison of DBS Targets in Obsessive-compulsive Disorder

Phase 3

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Procedure: Deep brain stimulation

• Registration Number: NCT01807403
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus \& nucleus accumbens). However, the efficacies of each target have never been compared directly.

This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be more efficacious.

Detailed Description

Deep brain stimulation has been proposed for severe and resistant obsessive-compulsive disorder (OCD). This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus \& nucleus accumbens). However, the efficacies of each target have never been compared directly.

Therefore, bilateral subthalamic and caudate electrodes will be implanted in severe OCD patients. Efficacy of stimulation at the different targets will be assessed using a double-blind randomised crossover design.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-08
• Status Verified: 2015-04
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Deep brain stimulation of subthalamic nucleus	Deep brain stimulation	Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Stimulation of subthalamic nucleus
Deep brain stimulation of caudate nucleus	Deep brain stimulation	Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker. Caudate nucleus stimulation
Deep brain stimulation of nucleus accumbens	Deep brain stimulation	Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.Nucleus accumbens stimulation.

Primary Outcome Measures

Name	Time	Method
Severity of symptoms after each phase	3 months	Severity as measured by the Yale-Brown Obsession and Compulsion scale

Secondary Outcome Measures

Name	Time	Method
Severity of symptoms after each phase	14 months	Severity as measured by the Yale-Brown Obsession and Compulsion scale

Trial Locations

Locations (1)

Centre d'investigation Clinique Pitié Salpêtrière; 🇫🇷 Paris, France