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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS | Active Comparator | 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 |
|
| SHAM tDCS | Placebo Comparator | The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the 10 first seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial dirrect current stimulation | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bation Remy, MD | Contact | 33437915565 | remy.bation@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Bation Remy, MD | CH le Vinatier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Le Vinatier | Recruiting | Bron | 69500 | France |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
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| Sham tDCS | Device |
|
% of improvement compare to baseline |
| 3 months after treatment |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |