Obsessive Compulsive Disorder
Conditions
Keywords
Obsessive compulsive disorder, deep brain stimulation, subthalamic nucleus
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.
Interventions
PROCEDUREdeep brain stimulation
Stimulator on followed by off
PROCEDURENo stimulation
Stimulator off followed by on
Sponsors
Assistance Publique - Hôpitaux de Paris
Marie-laure Welter
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Severe obsessive-compulsive disorder
Exclusion criteria
* Contraindication to magnetic resonance imaging (MRI) * Severe cognitive or behavioral disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale-Brown-Obession and Compulsion Scale (YBOCS) | 2 three-month periods | YBOCS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression(CGI) | 10 month follow-up but 2 3-month period for the cross-over | CGI |
| Montgomery and Asberg Depression Rating scale (MADRS) | 10 month follow-up but 2 3-month period for the cross-over | MADRS |
| Hospital Anxiety Depression scale (HAD-S) | 10 month follow-up but 2 3-month period for the cross-over | HAD-S |
| Sheehan Disability Scale (SDS) | 10 month follow-up but 2 3-month period for the cross-over | SDS |
| Brief Scale for Anxiety (BABS) | 10 month follow-up but 2 3-month period for the cross-over | BABS |
| Global assessment of function (GAF) | 10 month follow-up but 2 3-month period for the cross-over | GAF |
| neuropsychological tests | 10 month follow-up but 2 3-month period for the cross-over | STROOP, apathy scales |
| adverse event | 10 month follow-up but 2 3-month period for the cross-over | adverse event |
| Yale-Brown-Obession and Compulsion Scale (YBOCS) | observational follow-up at 22 month, 34 month and 46 month | — |
| Quality of life (SF-36) | observational follow-up at 22 month, 34 month and 46 month | — |
| Stimulation parameters | observational follow-up at 22 month, 34 month and 46 month | — |
| Social Adjustment scale self-report (SAS-SR) | 10 month follow-up but 2 3-month period for the cross-over | SAS-SR |
Countries
France
Outcome results
None listed