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Completed

NCT Number: NCT00169377

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

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.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe obsessive-compulsive disorder

Exclusion criteria

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

Treatment and study plan

Deep Brain Stimulation

Procedure

Stimulator on followed by off

No stimulation

Procedure

Stimulator off followed by on

Primary outcomes

  1. Yale-Brown-Obession and Compulsion Scale (YBOCS)

    Time frame: 2 three-month periods

    YBOCS

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Marie-laure Welter

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris

Registry information

Official study title

Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-compulsive Disorders

Important dates

Study start
2005
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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