tDCS for Treatment Resistant Obsessive Compulsive Disorder

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Transcranial Direct Current Stimulation (tDCS) to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder

Conditions
-----------------
Obsessive-Compulsive Disorder

Intervention / Treatment
-----------------
* Device: Active stimulation
* Device: Sham stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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 : at least 2 antidepressants (IRS type) (> 12 weeks) cognitive and comportment therapy since at least one year 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: 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 Meets another diagnosis of axe 1 of DSM-IV Current depressive or suicidal risks Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin lesions to the scalp (cuts, abrasions, rash) Epileptic patient Patient with a medical history of cranial trauma Patient unable to give his or hers informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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>10 sessions (1 per day during 2 week) of active tDCS stimulation | Device: Active stimulation<br>* Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).<br>|
| Sham Comparator: Sham Stimulation<br>10 sessions (1 per day during 2 week) of sham stimulation | Device: Sham stimulation<br>* Patients will receive a Sham stimulation during 30 mn<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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), | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCD, tDCS