Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Device: rTMS Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: Participants will be both males and females, 18-65 years of age included. diagnosis of OCD all the patients must have failed to respond to at least two different pharmacological treatment used for at least 6 weeks Affiliation to a social security system (recipient or assignee), Signed written inform consent form Exclusion Criteria: The exclusion criteria are a diagnosis of another psychiatric disorder (except for anxious disorders), a diagnosis of a significant active medical illness, pregnancy or other neurological illness In accordance with the safety criteria for rTMS, patients with a history of seizure or bearing pacemakers, mobile metal implants, implanted medical pumps, or metal clips placed inside the skull will also be excluded The patients won't be allowed to change their medication during the trial. The treatment must be stable at least 3 week before day 0. Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception or who is nursing, Patient under curators Patient hospitalized under duress Patient unable to give his or hers informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active stimulation<br>Active rTMS stimulation , 2 session per day during 10 days. | Device: rTMS Treatment<br>* 1 Hz rTMS<br>|
| Sham Comparator: Sham Stimulation<br>Sham rTMS stimulation , 2 session per day during 10 days. | Device: rTMS Treatment<br>* 1 Hz rTMS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS, D-B80 A/P