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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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It's a multicentric, randomized, controlled study concerning 100 patients with treatment-resistant obsessive compulsive disorders (OCD). The aim of this study is to evaluate the effect of transcranial direct current stimulation (tDCS) on OCD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Experimental | 10 sessions (1 per day during 2 week) of active tDCS stimulation |
|
| Sham Stimulation | Sham Comparator | 10 sessions (1 per day during 2 week) of sham stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active stimulation | Device | Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale (YBOCS) score | The primary objective of the study is to compare the change in Yale Brown Obsessive Compulsive Scale (YBOCS) scores from baseline to the week 2 (post-tDCS treatment) visit, between the two treatments groups | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale (YBOCS) | i. Change from baseline to month 1 in Yale Brown Obsessive Compulsive Scale (YBOCS) scores, between treatment groups. | Month 1 |
| Yale Brown Obsessive Compulsive Scale (YBOCS), |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Safety of the tDCS treatment :
| 3 Month |
Inclusion Criteria:
Meets criteria for obsessive compulsive disorder according to Diagnostic and Statistical Manual (DSM IV) with a "good insight" (BABS)
No current depressive and suicidal risks
No epileptic pathology
Age: Participants will be both males and females, 18-70 years of age included.
Chronic Obsessive compulsive disorder ( Total Y-BOCS>20 or Y-BOCS one subscale > 15)
Obsessive compulsive disorder resistant to pharmacology treatment :
Treatment stability (antidepressants) for more than 12 weeks without significant improvement.
Affiliation to a social security system (recipient or assignee),
Signed written inform consent form
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damien HEIT, MD | Centre Hospitalier Henri Laborit | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils De Lyon | Lyon | France | ||||
| CHU de Nantes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38827437 | Derived | Harika-Germaneau G, Heit D, Drapier D, Sauvaget A, Bation R, Chatard A, Doolub D, Wassouf I, Langbour N, Jaafari N. Treating refractory obsessive compulsive disorder with cathodal transcranial direct current stimulation over the supplementary motor area: a large multisite randomized sham-controlled double-blind study. Front Psychiatry. 2024 May 17;15:1338594. doi: 10.3389/fpsyt.2024.1338594. eCollection 2024. |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Sham stimulation | Device | Patients will receive a Sham stimulation during 30 mn |
|
ii. Response rate at month 3 in Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline, between treatment groups.
| Month 3 |
| Clinical Global Impression (CGI) | Change from baseline to month 1 in above scales between treatment groups; | Month 1 |
| Clinical Global Impression (CGI) | Change from baseline to month 3 in above scales between treatment groups; | Month 3 |
| Brown Assessment of Beliefs Scale (BABS) | Change from baseline to month 1 in above scales between treatment groups; | Month 1 |
| Brown Assessment of Beliefs Scale (BABS) | Change from baseline to month 3 in above scales between treatment groups; | Month 3 |
| Brief Anxiety Scale (BAS) | Change from baseline to month 1 in above scales between treatment groups; | Month 1 |
| Brief Anxiety Scale (BAS) | Change from baseline to month 3 in above scales between treatment groups; | Month 3 |
| Montgomery and Asberg Depression Rating Scale (MADRS) | Change from baseline to month 1 in above scales between treatment groups; | Month 1 |
| Montgomery and Asberg Depression Rating Scale (MADRS) | Change from baseline to month 3 in above scales between treatment groups; | Month 3 |
| Hospital Anxiety and Depression scale (HAD) | Change from baseline to month 1 in above scales between treatment groups; | Month 1 |
| Hospital Anxiety and Depression scale (HAD) | Change from baseline to month 3 in above scales between treatment groups; | Month 3 |
| Sheehan Disability Scale, (SDS) | Change from baseline to month 1 in above scales between treatment groups; | Month 1 |
| Sheehan Disability Scale, (SDS) | Change from baseline to month 3 in above scales between treatment groups; | Month 3 |
| Nantes |
| 44093 |
| France |
| Centre Hospitalier Henri Laborit | Poitiers | 86021 | France |
| C.H. Guillaume Regnier | Rennes | 35703 | France |