Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT00169377
First received: September 12, 2005
Last updated: July 22, 2008
Last verified: July 2008
History of Changes
  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
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:

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):

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 May 16, 2013