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According to the literature the lateral part of the Orbito Frontal Cortex (lOFC) is a relevant bilateral target for repetitive Trans-cranial Magnetic Stimulation (rTMS) in Obsessive Compulsive Disorder (OCD). Both hemispheres are concerned in terms of target.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Experimental | Active rTMS stimulation , 2 session per day during 10 days. |
|
| Sham Stimulation | Sham Comparator | Sham rTMS stimulation , 2 session per day during 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS Treatment | Device | 1 Hz rTMS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale score | Significant clinical change (≥ 25%) from baseline to two weeks after the treatment sequence, assessed by a significant reduction in YBOCS scores at day 25 | baseline and 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale | Significant clinical change of the YBOCS score (≥25% decrease), from baseline to day 70 | baseline and 70 days |
| general assessement functioning (GAF) | Change of the general assessement functioning (GAF) at day 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghina Harika-Germaneau, MD, PhD | Contact | +33 5 16 52 61 18 | ghina.harika.germaneau@ch-poitiers.fr | |
| Nematollah Jaafari, PR | Contact | +33 5 16 52 61 18 | nemat.jaafari@ch-poitiers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Ghina Harika-Germaneau | Centre Hospitalier Henri Laborit | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sorbonne University, Pitié-Salpêtrière Hospital | Recruiting | Paris | France |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| baseline and 25 days |
| general assessement functioning (GAF) | Change of the general assessement functioning (GAF) at day 70 | baseline and 70 days |
| Clinical Global Impression (CGI) | Clinical Global Impressions (CGI) change at day 25 | baseline and 25 days |
| Clinical Global Impression (CGI) | Clinical Global Impressions (CGI) change at day 70 | baseline and 70 days |
| Adverse events linked to the rTMS treatment | Number and types of adverse events linked to the rTMS treatment | 70 days |
| Centre Hospitalier Henri Laborit | Recruiting | Poitiers | 86021 | France |
|