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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Stimulator on followed by off
Stimulator off followed by on
Unnamed facility
Bordeaux, France
Unnamed facility
Clermont-Ferrand, France
Unnamed facility
Grenoble, France
Unnamed facility
Nantes, France
Yale-Brown-Obession and Compulsion Scale (YBOCS)
YBOCS
Time frame: 2 three-month periods
Global assessment of function (GAF)
GAF
Time frame: 10 month follow-up but 2 3-month period for the cross-over
Clinical Global Impression(CGI)
CGI
Time frame: 10 month follow-up but 2 3-month period for the cross-over
Montgomery and Asberg Depression Rating scale (MADRS)
MADRS
Time frame: 10 month follow-up but 2 3-month period for the cross-over
Hospital Anxiety Depression scale (HAD-S)
HAD-S
Time frame: 10 month follow-up but 2 3-month period for the cross-over
Sheehan Disability Scale (SDS)
SDS
Time frame: 10 month follow-up but 2 3-month period for the cross-over
Brief Scale for Anxiety (BABS)
BABS
Time frame: 10 month follow-up but 2 3-month period for the cross-over
Social Adjustment scale self-report (SAS-SR)
SAS-SR
Time frame: 10 month follow-up but 2 3-month period for the cross-over
neuropsychological tests
STROOP, apathy scales
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Unnamed facility
Nice, France
Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière
Paris, France
Saint-Anne
Paris, France
Unnamed facility
Poitiers, France
Unnamed facility
Rennes, France
Unnamed facility
Toulouse, France
Time frame: 10 month follow-up but 2 3-month period for the cross-over
adverse event
adverse event
Time frame: 10 month follow-up but 2 3-month period for the cross-over
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