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Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) as an add-on Treatment for Resistant OCD

Phase 2
Completed
Conditions
Obsessive-Compulsive Disorder
Interventions
Procedure: repetitive transcranial magnetic stimulation (rTMS)
Registration Number
NCT01043900
Lead Sponsor
University of Sao Paulo General Hospital
Brief Summary

OCD is a chronic condition with a high rate of poor responders to conventional treatments, such as antidepressants and psychotherapy. Chronic symptoms can lead to important social impairment and suffering for patients and families.

The present study aims to investigate if the addition of transcranial magnetic stimulation can provide enhanced response to conventional treatment.

Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.

Detailed Description

The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 6 consecutive weeks. Each session lasts up to 30 minutes.

Side effects include scalp discomfort and mild headache. No anesthesia is required.

Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results. The present technique has never been employed in previous studies, but risks are insignificant

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • resistant OCD patients: maximum 25% reduction in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores after at least 3 adequate trials with serotonin reuptake inhibitors (SRI) (including clomipramine) and 20 hours of cognitive behavioral therapy (CBT) or documented intolerance to either treatment.
Exclusion Criteria
  • metallic cerebral implants
  • history of severe trauma or brain injury
  • organic brain disease
  • severe somatic disease
  • history of drug dependence
  • chronic psychosis
  • present manic state

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sham rTMSrepetitive transcranial magnetic stimulation (rTMS)Patients with stable medication regimen receiving 30 daily sessions of PLACEBO rTMS delivered to the right dorsolateral prefrontal cortex
Active rTMSrepetitive transcranial magnetic stimulation (rTMS)Patients with stable medication regimen receiving 30 daily sessions of active rTMS delivered to the right dorsolateral prefrontal cortex
Primary Outcome Measures
NameTimeMethod
A reduction of at least 30 % in the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores and an "improved" or "much improved" score on the Clinical Global Impression (CGI) improvement scale by the end of follow-up3 - 6 months
Secondary Outcome Measures
NameTimeMethod
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