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

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ClinicalTrials.gov Identifier: NCT00169377
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Marie-laure Welter, Groupe Hospitalier Pitie-Salpetriere

September 12, 2005
September 15, 2005
March 22, 2018
October 2005
Not Provided
Yale-Brown-Obession and Compulsion Scale (YBOCS) [ Time Frame: 2 three-month periods ]
YBOCS
Not Provided
Complete list of historical versions of study NCT00169377 on ClinicalTrials.gov Archive Site
  • Global assessment of function (GAF) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    GAF
  • Clinical Global Impression(CGI) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    CGI
  • Montgomery and Asberg Depression Rating scale (MADRS) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    MADRS
  • Hospital Anxiety Depression scale (HAD-S) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    HAD-S
  • Sheehan Disability Scale (SDS) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    SDS
  • Brief Scale for Anxiety (BABS) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    BABS
  • Social Adjustment scale self-report (SAS-SR) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    SAS-SR
  • neuropsychological tests [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    STROOP, apathy scales
  • adverse event [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    adverse event
  • Yale-Brown-Obession and Compulsion Scale (YBOCS) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  • Global assessment of function (GAF) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  • Clinical Global Impression(CGI) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  • Montgomery and Asberg Depression Rating scale (MADRS) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  • Hospital Anxiety Depression scale (HAD-S) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  • Sheehan Disability Scale (SDS) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  • Social Adjustment scale self-report (SAS-SR) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  • Quality of life (SF-36) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  • neuropsychological tests [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  • adverse event [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  • Stimulation parameters [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obsessive Compulsive Disorder
  • Procedure: deep brain stimulation
    Stimulator on followed by off
  • Procedure: No stimulation
    Stimulator off followed by on
  • Active Comparator: Group A
    Deep brain stimulation on followed by off
    Interventions:
    • Procedure: deep brain stimulation
    • Procedure: No stimulation
  • Sham Comparator: Group B
    No stimulation, deep brain stimulation off followed by on
    Interventions:
    • Procedure: deep brain stimulation
    • Procedure: No stimulation

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

Inclusion Criteria:

  • Severe obsessive-compulsive disorder

Exclusion Criteria:

  • Contraindication to magnetic resonance imaging (MRI)
  • Severe cognitive or behavioral disorders
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00169377
P030422
Yes
Not Provided
Not Provided
Marie-laure Welter, Groupe Hospitalier Pitie-Salpetriere
Marie-laure Welter
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Luc Mallet, MD, PhD Assistance Publique - Hôpitaux de Paris
Groupe Hospitalier Pitie-Salpetriere
March 2018

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