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

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-compulsive Disorders

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Procedure: deep brain stimulation
* Procedure: No stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe obsessive-compulsive disorder Exclusion Criteria: Contraindication to magnetic resonance imaging (MRI) Severe cognitive or behavioral disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Deep brain stimulation on followed by off | Procedure: deep brain stimulation<br>* Stimulator on followed by off<br>Procedure: No stimulation<br>* Stimulator off followed by on<br>|
| Sham Comparator: Group B<br>No stimulation, deep brain stimulation off followed by on | Procedure: deep brain stimulation<br>* Stimulator on followed by off<br>Procedure: No stimulation<br>* Stimulator off followed by on<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown-Obession and Compulsion Scale (YBOCS) | YBOCS | 2 three-month periods | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive compulsive disorder, deep brain stimulation, subthalamic nucleus