tDCS as an add-on Treatment in SSRI-resistant OCD (TDCSTOC)

Hôpital le Vinatier

Status: Unknown

Conditions: Obsessive-Compulsive Disorder

Treatments: Device: Sham tDCS; Device: transcranial dirrect current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02407288

CSR G01

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

active tDCS

Active Comparator group

Description:

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

Treatment:

Device: transcranial dirrect current stimulation

SHAM tDCS

Placebo Comparator group

Description:

The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the 10 first seconds.

Treatment:

Device: Sham tDCS