Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Assistance Publique - Hôpitaux de Paris | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Deep brain stimulation on followed by off |
|
| Group B | Sham Comparator | No stimulation, deep brain stimulation off followed by on |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep brain stimulation | Procedure | Stimulator on followed by off |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Yale-Brown-Obession and Compulsion Scale (YBOCS) | YBOCS | 2 three-month periods |
| Measure | Description | Time Frame |
|---|---|---|
| Global assessment of function (GAF) | GAF | 10 month follow-up but 2 3-month period for the cross-over |
| Clinical Global Impression(CGI) | CGI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luc Mallet, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux | France | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20951978 | Derived | Le Jeune F, Verin M, N'Diaye K, Drapier D, Leray E, Du Montcel ST, Baup N, Pelissolo A, Polosan M, Mallet L, Yelnik J, Devaux B, Fontaine D, Chereau I, Bourguignon A, Peron J, Sauleau P, Raoul S, Garin E, Krebs MO, Jaafari N, Millet B; French Stimulation dans le trouble obsessionnel compulsif (STOC) study group. Decrease of prefrontal metabolism after subthalamic stimulation in obsessive-compulsive disorder: a positron emission tomography study. Biol Psychiatry. 2010 Dec 1;68(11):1016-22. doi: 10.1016/j.biopsych.2010.06.033. Epub 2010 Oct 16. | |
| 20621362 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No stimulation |
| Procedure |
Stimulator off followed by on |
|
| 10 month follow-up but 2 3-month period for the cross-over |
| Montgomery and Asberg Depression Rating scale (MADRS) | MADRS | 10 month follow-up but 2 3-month period for the cross-over |
| Hospital Anxiety Depression scale (HAD-S) | HAD-S | 10 month follow-up but 2 3-month period for the cross-over |
| Sheehan Disability Scale (SDS) | SDS | 10 month follow-up but 2 3-month period for the cross-over |
| Brief Scale for Anxiety (BABS) | BABS | 10 month follow-up but 2 3-month period for the cross-over |
| Social Adjustment scale self-report (SAS-SR) | SAS-SR | 10 month follow-up but 2 3-month period for the cross-over |
| neuropsychological tests | STROOP, apathy scales | 10 month follow-up but 2 3-month period for the cross-over |
| adverse event | adverse event | 10 month follow-up but 2 3-month period for the cross-over |
| Yale-Brown-Obession and Compulsion Scale (YBOCS) | observational follow-up at 22 month, 34 month and 46 month |
| Global assessment of function (GAF) | observational follow-up at 22 month, 34 month and 46 month |
| Clinical Global Impression(CGI) | observational follow-up at 22 month, 34 month and 46 month |
| Montgomery and Asberg Depression Rating scale (MADRS) | observational follow-up at 22 month, 34 month and 46 month |
| Hospital Anxiety Depression scale (HAD-S) | observational follow-up at 22 month, 34 month and 46 month |
| Sheehan Disability Scale (SDS) | observational follow-up at 22 month, 34 month and 46 month |
| Social Adjustment scale self-report (SAS-SR) | 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 |
| neuropsychological tests | observational follow-up at 22 month, 34 month and 46 month |
| adverse event | observational follow-up at 22 month, 34 month and 46 month |
| Stimulation parameters | observational follow-up at 22 month, 34 month and 46 month |
| 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 |
| Derived |
| Bourredjem A, Pelissolo A, Rotge JY, Jaafari N, Machefaux S, Quentin S, Bui E, Bruno N, Pochon JB, Polosan M, Baup N, Papetti F, Chereau I, Arbus C, Mallet L, du Montcel ST; French "Stimulation dans le Trouble Obsessionnel Compulsif (STOC)" Study Group. A video Clinical Global Impression (CGI) in obsessive compulsive disorder. Psychiatry Res. 2011 Mar 30;186(1):117-22. doi: 10.1016/j.psychres.2010.06.021. Epub 2011 Feb 12. |
| 19005196 | Derived | Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. |