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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

Brief Summary:
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 or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Procedure: deep brain stimulation Procedure: No stimulation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2005
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group A
Deep brain stimulation on followed by off
Procedure: deep brain stimulation
Stimulator on followed by off
Procedure: No stimulation
Stimulator off followed by on
Sham Comparator: Group B
No stimulation, deep brain stimulation off followed by on
Procedure: deep brain stimulation
Stimulator on followed by off
Procedure: No stimulation
Stimulator off followed by on



Primary Outcome Measures :
  1. Yale-Brown-Obession and Compulsion Scale (YBOCS) [ Time Frame: 2 three-month periods ]
    YBOCS


Secondary Outcome Measures :
  1. Global assessment of function (GAF) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    GAF

  2. Clinical Global Impression(CGI) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    CGI

  3. Montgomery and Asberg Depression Rating scale (MADRS) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    MADRS

  4. Hospital Anxiety Depression scale (HAD-S) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    HAD-S

  5. Sheehan Disability Scale (SDS) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    SDS

  6. Brief Scale for Anxiety (BABS) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    BABS

  7. Social Adjustment scale self-report (SAS-SR) [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    SAS-SR

  8. neuropsychological tests [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    STROOP, apathy scales

  9. adverse event [ Time Frame: 10 month follow-up but 2 3-month period for the cross-over ]
    adverse event

  10. Yale-Brown-Obession and Compulsion Scale (YBOCS) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  11. Global assessment of function (GAF) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  12. Clinical Global Impression(CGI) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  13. Montgomery and Asberg Depression Rating scale (MADRS) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  14. Hospital Anxiety Depression scale (HAD-S) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  15. Sheehan Disability Scale (SDS) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  16. Social Adjustment scale self-report (SAS-SR) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  17. Quality of life (SF-36) [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  18. neuropsychological tests [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  19. adverse event [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]
  20. Stimulation parameters [ Time Frame: observational follow-up at 22 month, 34 month and 46 month ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe obsessive-compulsive disorder

Exclusion Criteria:

  • Contraindication to magnetic resonance imaging (MRI)
  • Severe cognitive or behavioral disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169377


Locations
France
Bordeaux, France
Clermont-Ferrand, France
Grenoble, France
Nantes, France
Nice, France
Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière
Paris, France
Saint-Anne
Paris, France
Poitiers, France
Rennes, France
Toulouse, France
Sponsors and Collaborators
Marie-laure Welter
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Luc Mallet, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marie-laure Welter, MD, PhD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT00169377     History of Changes
Other Study ID Numbers: P030422
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by Marie-laure Welter, Groupe Hospitalier Pitie-Salpetriere:
Obsessive compulsive disorder
deep brain stimulation
subthalamic nucleus

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders