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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00169377
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 24, 2008
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Procedure: deep brain stimulation Procedure: Off Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-Compulsive Disorders
Study Start Date : October 2005
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
Stimulator on followed by off
Procedure: deep brain stimulation
Stimulator on followed by off
Sham Comparator: B
Stimulator off followed by on
Procedure: Off
Stimulator off followed by on

Outcome Measures

Primary Outcome Measures :
  1. YBOCS [ Time Frame: 2 three-month periods ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Severe obsessive-compulsive disorder

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169377

Bordeaux, France
Clermont-Ferrand, France
Grenoble, France
Nantes, France
Nice, France
Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière
Paris, France
Paris, France
Poitiers, France
Rennes, France
Toulouse, France
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Luc Mallet, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: cecile Jourdain, Assistance Publique - Hôpitaux de Paris Delegation Research Clinical
ClinicalTrials.gov Identifier: NCT00169377     History of Changes
Other Study ID Numbers: P030422
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: July 2008

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:
Obsessive compulsive disorder
deep brain stimulation
subthalamic nucleus

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders