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

NCT ID: NCT00169377

Last Updated: 2018-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-05-31

Brief Summary

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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

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Conditions

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Obsessive Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

Deep brain stimulation on followed by off

Group Type ACTIVE_COMPARATOR

deep brain stimulation

Intervention Type PROCEDURE

Stimulator on followed by off

No stimulation

Intervention Type PROCEDURE

Stimulator off followed by on

Group B

No stimulation, deep brain stimulation off followed by on

Group Type SHAM_COMPARATOR

deep brain stimulation

Intervention Type PROCEDURE

Stimulator on followed by off

No stimulation

Intervention Type PROCEDURE

Stimulator off followed by on

Interventions

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deep brain stimulation

Stimulator on followed by off

Intervention Type PROCEDURE

No stimulation

Stimulator off followed by on

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Severe obsessive-compulsive disorder

Exclusion Criteria

* Contraindication to magnetic resonance imaging (MRI)
* Severe cognitive or behavioral disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

Marie-laure Welter

OTHER

Sponsor Role lead

Responsible Party

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Marie-laure Welter

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Luc Mallet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Bordeaux, , France

Site Status

Clermont-Ferrand, , France

Site Status

Grenoble, , France

Site Status

Nantes, , France

Site Status

Nice, , France

Site Status

Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière

Paris, , France

Site Status

Saint-Anne

Paris, , France

Site Status

Poitiers, , France

Site Status

Rennes, , France

Site Status

Toulouse, , France

Site Status

Countries

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France

References

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Le Jeune F, Verin 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.

Reference Type DERIVED
PMID: 20951978 (View on PubMed)

Bourredjem A, Pelissolo A, Rotge JY, Jaafari N, Machefaux S, Quentin S, Bui E, Bruno N, Pochon JB, Polosan M, Baup N, Papetti F, Chereau 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.

Reference Type DERIVED
PMID: 20621362 (View on PubMed)

Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes 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, Verin 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.

Reference Type DERIVED
PMID: 19005196 (View on PubMed)

Other Identifiers

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P030422

Identifier Type: -

Identifier Source: org_study_id

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