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

Study Overview
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Brief Summary
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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
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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

Official Title
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Right Prefrontal High Frequency rTMS in Treatment of Resistant OCD: a Double Blind, Randomized Controlled Trial

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Procedure: repetitive transcranial magnetic stimulation (rTMS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham rTMS<br>Patients with stable medication regimen receiving 30 daily sessions of PLACEBO rTMS delivered to the right dorsolateral prefrontal cortex | Procedure: repetitive transcranial magnetic stimulation (rTMS)<br>* 30 daily sessions: each with 40 trains of 5 seconds at 10Hz, with a 25 second inter-train interval, at an intensity of 110% of motor threshold. Site: Right Dorsolateral Prefrontal Cortex<br>* Other names: TMS;|
| Active Comparator: Active rTMS<br>Patients with stable medication regimen receiving 30 daily sessions of active rTMS delivered to the right dorsolateral prefrontal cortex | Procedure: repetitive transcranial magnetic stimulation (rTMS)<br>* 30 daily sessions: each with 40 trains of 5 seconds at 10Hz, with a 25 second inter-train interval, at an intensity of 110% of motor threshold. Site: Right Dorsolateral Prefrontal Cortex<br>* Other names: TMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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-up |  | 3 - 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive-Compulsive Disorder, rTMS, Transcranial Magnetic Stimulation, treatment, randomized controlled trials