Obsessive-Compulsive Disorder
Conditions
Keywords
OCD
Brief summary
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
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.
Interventions
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
DEVICESham tDCS
Sponsors
Hôpital le Vinatier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| score improvement on the Yale Brown Obsessive and Compulsive Scale after one month | 1 month after treatment | % of improvement compare to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of responders on the YBOCS | 1 month after treatment | 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) |
| score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months | 3 months after treatment | % of improvement compare to baseline |
Countries
France
Contacts
Primary ContactBation Remy, MD
Outcome results
None listed