tDCS as an add-on Treatment in SSRI-resistant OCD

Study Overview
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Brief Summary
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The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder

Detailed Description
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Total number of scheduled patients to be recruited: 46 We used the effect size of the study of Ruffini and colleagues (2009) in which rTMS was used to target the left orbito frontal cortex to calculate the number of patients to be recruited. With a risk alpha of 5%, a power of 80%, the number of patients to be included was 46 with an anticipated rate of 10% of lost to follow-up patients. (calculation was made on the http://www.spc.univ-lyon1.fr/mfcalc/NSN/assistant.htm) Statistical analysis to address the primary and secondary objectives: Chi squared test will be applied for quantitative data.

Official Title
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Transcranial Direct Current Stimulation as an add-on Treatment in SSRI-resistant Obsessive Compulsive Disorder : a Randomized Clinical Trial

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Device: transcranial dirrect current stimulation
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed with OCD according to DSM V criteria YBOCS score of 16 and above, stable (<20% of variation) during at least one month. have received for at least 12 weeks of which 6 weeks was either at the maximum tolerated dose or alternatively the manufacturer's recommended maxi- mum daily dose. age between 18 and 70 voluntary and competent to consent Exclusion Criteria: Major depressive disorder diagnosed with the DSM V criteria with a MADRS score >30 (actual) schizophrenia and other psychotic disorder drugs or alcohol abuse acutely suicidal significant head injury, or of any neurosurgical procedure with implanted material pregnant women

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active tDCS<br>patients will received 2 sessions per day for 5 consecutive days. Each session will last 20 minutes. The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline | Device: transcranial dirrect current stimulation<br>* The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline<br>* Other names: tdcs;|
| Placebo Comparator: SHAM tDCS<br>The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the 10 first seconds. | Device: Sham tDCS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score improvement on the Yale Brown Obsessive and Compulsive Scale after one month | % of improvement compare to baseline | 1 month after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of responders on the YBOCS | Number of responders (decrease >35%) on the Yale Brown Obsessive and Compulsive Scale) or a score of 2 or less on the CGI-I (much or very much improved) | 1 month after treatment | 
| score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months | % of improvement compare to baseline | 3 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD