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

September 12, 2005
July 22, 2008
October 2005
Not Provided
YBOCS [ Time Frame: 2 three-month periods ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00169377 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)
Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-Compulsive Disorders

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obsessive Compulsive Disorder
  • Procedure: deep brain stimulation
    Stimulator on followed by off
  • Procedure: Off
    Stimulator off followed by on
  • Active Comparator: A
    Stimulator on followed by off
    Intervention: Procedure: deep brain stimulation
  • Sham Comparator: B
    Stimulator off followed by on
    Intervention: Procedure: Off

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 2007
Not Provided

Inclusion Criteria:

  • Severe obsessive-compulsive disorder

Exclusion Criteria:

  • Contraindication to magnetic resonance imaging (MRI)
  • Severe cognitive or behavioral disorders
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00169377
P030422
Yes
cecile Jourdain, Assistance Publique - Hôpitaux de Paris Delegation Research Clinical
Groupe Hospitalier Pitie-Salpetriere
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Luc Mallet, MD, PhD Assistance Publique - Hôpitaux de Paris
Groupe Hospitalier Pitie-Salpetriere
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP