Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)

Phase 1

Completed

• Conditions: Obsessive Compulsive Disorder
• Interventions: Procedure: deep brain stimulation; Procedure: No stimulation

• Registration Number: NCT00169377
• Lead Sponsor: Marie-laure Welter

Brief Summary

Obsessive-compulsive disorder is a disabling and frequent disorder. In some patients, the medical treatment is ineffective. The pathophysiology of this disease is still unknown. Some data suggest that basal ganglia dysfunction could participate in the occurrence of OCD. The aim of this study is to evaluate the efficacy of subthalamic nucleus high-frequency stimulation in patients with severe OCD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Study Start: 2005-10
• Study Completion: 2007-05
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Severe obsessive-compulsive disorder

Exclusion Criteria

• Contraindication to magnetic resonance imaging (MRI)
• Severe cognitive or behavioral disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	No stimulation	Deep brain stimulation on followed by off
Group A	deep brain stimulation	Deep brain stimulation on followed by off
Group B	deep brain stimulation	No stimulation, deep brain stimulation off followed by on
Group B	No stimulation	No stimulation, deep brain stimulation off followed by on

Primary Outcome Measures

Name	Time	Method
Yale-Brown-Obession and Compulsion Scale (YBOCS)	2 three-month periods	YBOCS

Secondary Outcome Measures

Name	Time	Method
Global assessment of function (GAF)	observational follow-up at 22 month, 34 month and 46 month
Clinical Global Impression(CGI)	observational follow-up at 22 month, 34 month and 46 month
Montgomery and Asberg Depression Rating scale (MADRS)	observational follow-up at 22 month, 34 month and 46 month
Hospital Anxiety Depression scale (HAD-S)	observational follow-up at 22 month, 34 month and 46 month
Brief Scale for Anxiety (BABS)	10 month follow-up but 2 3-month period for the cross-over	BABS
Sheehan Disability Scale (SDS)	observational follow-up at 22 month, 34 month and 46 month
neuropsychological tests	observational follow-up at 22 month, 34 month and 46 month
adverse event	observational follow-up at 22 month, 34 month and 46 month
Social Adjustment scale self-report (SAS-SR)	observational follow-up at 22 month, 34 month and 46 month
Yale-Brown-Obession and Compulsion Scale (YBOCS)	observational follow-up at 22 month, 34 month and 46 month
Quality of life (SF-36)	observational follow-up at 22 month, 34 month and 46 month
Stimulation parameters	observational follow-up at 22 month, 34 month and 46 month

Trial Locations

Locations (2)

Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France

Saint-Anne; 🇫🇷 Paris, France