NCT02407288

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Hôpital le Vinatier · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
DEVICE	transcranial dirrect current stimulation	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	Sham tDCS

Timeline

• Start date: 2015-03-12
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2015-04-02
• Last updated: 2017-05-08

Locations

1 site across 1 country: France