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

Sponsors and Collaborators:	Groupe Hospitalier Pitie-Salpetriere 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

MedlinePlus related topics: Obsessive-Compulsive Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-Compulsive Disorders

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
A: Active Comparator Stimulator on followed by off	Procedure: deep brain stimulation Stimulator on followed by off
B: Sham Comparator 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
Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière
Paris, France

Bordeaux, France

Clermont-Ferrand, France

Grenoble, France

Nantes, France
Saint-Anne
Paris, France

Poitiers, France

Rennes, France

Toulouse, France

Nice, 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 indexed to this study:

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

Keywords provided by Groupe Hospitalier Pitie-Salpetriere:

Obsessive compulsive disorder
deep brain stimulation
subthalamic nucleus

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 13, 2009