tDCS Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder-Pilot Study

Study Overview
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Brief Summary
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The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal cortex and cathodic stimulation on supplementary motor areas is an effective treatment for patients with resistant and severe obsessive compulsive disorders.

Official Title
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Transcranial Direct Current Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorders -Pilot Study (tDCS-TOC Pilot)

Conditions
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Obsessive-compulsive Disorders and Symptoms

Intervention / Treatment
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* Other: bifocal stimulation with tDCS


Participation Criteria
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Eligibility Criteria
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Patients must present all of the following criteria in order to be eligible: Inclusion Criteria: Meets criteria for obsessive compulsive disorder according to DSM-IV with a good insight (BABS), Age: Participants will be both males and females, 18-70 years of age included. No current depressive and suicidal risks, No epileptic pathology, Chronic evolution ( Total Y-BOCS>20 ), Obsessive compulsive disorder resistant to pharmacology treatment, at least 2 antidepressants (type IRS) or cognitive and comportment therapy since at least one year, Stability treatment (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 Meets another diagnosis of axe 1 of DSM-IV, Current depressive or suicidal risks, Patient with a benzodiazepine treatment, 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
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bifocal stimulation<br>Transcranial direct current Bifocal stimulation | Other: bifocal stimulation with tDCS<br>* Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is used to show that bifocal tDCS with anodal stimulation on OFC and cathodic stimulation on the SMA is an effective treatment | Score improvement on the Y-BOCS after 14 days compared to the baseline | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the persistence of therapeutic response at 45 days | Score improvement on the Y-BOCS after 45 days compared to the baseline | Day 45 | 
| Evaluate the persistence of therapeutic response at 105 days | Score improvement on the Y-BOCS after 105 days compared to the baseline | Day 105 | 
| Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days | Score improvement of Hamilton and HDRS scales between the baseline and day 14 | Day 14 | 
| Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days | Score improvement of Hamilton and HDRS scales between the baseline and day 45 | Day 45 | 
| Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days | Score improvement of Hamilton and HDRS scales between the baseline and day 105 | Day 105 | 
| Evaluate the effect of tDCS on the quality of life at day 14 | Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 14 | Day 14 | 
| Evaluate the effect of tDCS on the quality of life at day 45 | Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 45 | Day 45 | 
| Evaluate the effect of tDCS on global functioning at day 14 | Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 14 | Day 14 | 
| Evaluate the effect of tDCS on global functioning at day 45 | Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 45 | Day 45 | 
| Evaluate the effect of tDCS on social adjustment at day 14 | Improvement of SAS (Social Adjustment Scale) scale between baseline and day 14 | Day 14 | 
| Evaluate the effect of tDCS on social adjustement at day 45 | Improvement of SAS (Social Adjustment Scale) scale between baseline and day 45 | Day 45 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Direct Current Stimulation, Supplementary motor area, Orbitofrontal cortex