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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169377
First Posted: September 15, 2005
Last Update Posted: July 24, 2008
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.
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
  Purpose
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 Intervention Phase
Obsessive Compulsive Disorder Procedure: deep brain stimulation Procedure: Off Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Pitie-Salpetriere:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: October 2005
Study Completion Date: May 2007
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Locations
France
Bordeaux, France
Clermont-Ferrand, France
Grenoble, France
Nantes, France
Nice, France
Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière
Paris, France
Saint-Anne
Paris, France
Poitiers, France
Rennes, France
Toulouse, France
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Assistance Publique - Hôpitaux de Paris
Investigators
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):
Le Jeune F, Vérin M, N'Diaye K, Drapier D, Leray E, Du Montcel ST, Baup N, Pelissolo A, Polosan M, Mallet L, Yelnik J, Devaux B, Fontaine D, Chereau I, Bourguignon A, Peron J, Sauleau P, Raoul S, Garin E, Krebs MO, Jaafari N, Millet B; French Stimulation dans le trouble obsessionnel compulsif (STOC) study group. Decrease of prefrontal metabolism after subthalamic stimulation in obsessive-compulsive disorder: a positron emission tomography study. Biol Psychiatry. 2010 Dec 1;68(11):1016-22. doi: 10.1016/j.biopsych.2010.06.033. Epub 2010 Oct 16.
Bourredjem A, Pelissolo A, Rotge JY, Jaafari N, Machefaux S, Quentin S, Bui E, Bruno N, Pochon JB, Polosan M, Baup N, Papetti F, Chéreau I, Arbus C, Mallet L, du Montcel ST; French "Stimulation dans le Trouble Obsessionnel Compulsif (STOC)" Study Group. A video Clinical Global Impression (CGI) in obsessive compulsive disorder. Psychiatry Res. 2011 Mar 30;186(1):117-22. doi: 10.1016/j.psychres.2010.06.021. Epub 2011 Feb 12.
Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chéreau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardès S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Vérin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum in: N Engl J Med. 2009 Sep 3;361(10):1027.

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 Submitted: September 12, 2005
First Posted: September 15, 2005
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:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders


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