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

Sponsor:	Groupe Hospitalier Pitie-Salpetriere
Collaborator:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:	NCT00169377

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 I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Obsessive-Compulsive Disorder

U.S. FDA Resources

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

Primary Outcome Measures:

YBOCS [ Time Frame: 2 three-month periods ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169377

Locations

France

Bordeaux, France

Clermont-Ferrand, France

Grenoble, France

Nantes, France

Nice, France
Saint-Anne
Paris, France
Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière
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

No publications provided by Groupe Hospitalier Pitie-Salpetriere

Additional 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. 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. 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.

Responsible Party:	cecile Jourdain, Assistance Publique - Hôpitaux de Paris Delegation Research Clinical
ClinicalTrials.gov Identifier:	NCT00169377 History of Changes
Other Study ID Numbers:	P030422
Study First Received:	September 12, 2005
Last Updated:	July 22, 2008
Health Authority:	France: Ministry of Health

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:

Obsessive compulsive disorder
deep brain stimulation
subthalamic nucleus

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012