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NCT00169377 Clinical Trial

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

Obsessive Compulsive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00169377
Other study ID # P030422
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 12, 2005
Last updated March 20, 2018
Start date October 2005
Est. completion date May 2007

Study information
Verified date March 2018
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Severe obsessive-compulsive disorder

Exclusion Criteria:

- Contraindication to magnetic resonance imaging (MRI)

- Severe cognitive or behavioral disorders

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• deep brain stimulation
Stimulator on followed by off
• No stimulation
Stimulator off followed by on

Locations
Country Name City State
France Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière Paris
France Saint-Anne Paris

Sponsors (2)
Lead Sponsor Collaborator
Marie-laure Welter Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Yale-Brown-Obession and Compulsion Scale (YBOCS) YBOCS 2 three-month periods
Secondary Global assessment of function (GAF) GAF 10 month follow-up but 2 3-month period for the cross-over
Secondary Clinical Global Impression(CGI) CGI 10 month follow-up but 2 3-month period for the cross-over
Secondary Montgomery and Asberg Depression Rating scale (MADRS) MADRS 10 month follow-up but 2 3-month period for the cross-over
Secondary Hospital Anxiety Depression scale (HAD-S) HAD-S 10 month follow-up but 2 3-month period for the cross-over
Secondary Sheehan Disability Scale (SDS) SDS 10 month follow-up but 2 3-month period for the cross-over
Secondary Brief Scale for Anxiety (BABS) BABS 10 month follow-up but 2 3-month period for the cross-over
Secondary Social Adjustment scale self-report (SAS-SR) SAS-SR 10 month follow-up but 2 3-month period for the cross-over
Secondary neuropsychological tests STROOP, apathy scales 10 month follow-up but 2 3-month period for the cross-over
Secondary adverse event adverse event 10 month follow-up but 2 3-month period for the cross-over
Secondary Yale-Brown-Obession and Compulsion Scale (YBOCS) observational follow-up at 22 month, 34 month and 46 month
Secondary Global assessment of function (GAF) observational follow-up at 22 month, 34 month and 46 month
Secondary Clinical Global Impression(CGI) observational follow-up at 22 month, 34 month and 46 month
Secondary Montgomery and Asberg Depression Rating scale (MADRS) observational follow-up at 22 month, 34 month and 46 month
Secondary Hospital Anxiety Depression scale (HAD-S) observational follow-up at 22 month, 34 month and 46 month
Secondary Sheehan Disability Scale (SDS) observational follow-up at 22 month, 34 month and 46 month
Secondary Social Adjustment scale self-report (SAS-SR) observational follow-up at 22 month, 34 month and 46 month
Secondary Quality of life (SF-36) observational follow-up at 22 month, 34 month and 46 month
Secondary neuropsychological tests observational follow-up at 22 month, 34 month and 46 month
Secondary adverse event observational follow-up at 22 month, 34 month and 46 month
Secondary Stimulation parameters observational follow-up at 22 month, 34 month and 46 month
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