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

This study has been completed.
Study NCT00169377.   Last updated on July 22, 2008.   Information provided by Groupe Hospitalier Pitie-Salpetriere

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Descriptive Information Fields
Brief Title  Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)
Official Title  Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-Compulsive Disorders
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
Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary Outcome Measure  YBOCS [ Time Frame: 2 three-month periods ] [ Designated as safety issue: No ]
Secondary Outcome Measure  MOCI, BABS, CGI, MADRS, HAD, GAF, SAS, neuropsychological tests, SAS-SR, Adverse event [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ] [ Designated as safety issue: Yes ]
Condition  Obsessive Compulsive Disorder
Intervention  Procedure: deep brain stimulation
Procedure: Off
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  16
Start Date  October 2005
Completion Date May 2007
Eligibility Criteria 

Inclusion Criteria:

  • Severe obsessive-compulsive disorder

Exclusion Criteria:

  • Contraindication to magnetic resonance imaging (MRI)
  • Severe cognitive or behavioral disorders
Gender Both
Ages 18 Years to 60 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  France
Administrative Information Fields
NCT ID  NCT00169377
Organization ID P030422
Secondary IDs ††
Study Sponsor  Groupe Hospitalier Pitie-Salpetriere
Collaborators †† Assistance Publique - Hôpitaux de Paris
Investigators 
Principal Investigator:     Luc Mallet, MD, PhD     Assistance Publique - Hôpitaux de Paris    
Information Provided By Groupe Hospitalier Pitie-Salpetriere
Verification Date July 2008
First Received Date  September 12, 2005
Last Updated Date July 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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