Efficacy Study of Transcranial Magnetic Stimulation for Treatment of Obsessive-Compulsive Disorder

Study Overview
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Brief Summary
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This study aimed at verifying whether sessions of repetitive transcranial magnetic stimulation over a certain brain area (the supplementary motor area) could be useful in the relief of Obsessive-Compulsive Disorder symptoms.

Detailed Description
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Patients were randomly administered either real (n = 12) or sham (n = 10) rTMS, once a day, 5 days a week, for 2 weeks. Randomization was performed according to a computer-generated schedule. Subjects and scale-rater physician were blind to treatment status of individuals. Only the rTMS administrator was aware of group allocations. Treatment response was assessed by self-and clinician-rated scales before treatment, immediately after treatment and 3 months thereafter, with the same examiner following a subject throughout the study. All patients included in the study had failed adequate pharmacological treatment for at least 2 antiobsessional drugs. Their prescription drugs were continued without change in dosage regimens throughout the study.

Official Title
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A Randomized Double-blind Trial of Repetitive Transcranial Magnetic Stimulation in Obsessive -Compulsive Disorder With Three Months Follow-up

Conditions
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Obsessive Compulsive Disorder

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
* Device: Sham repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 60 years diagnosis of obsessive-compulsive disorder (OCD) according to DSM-IV-TR criteria and having OCD of at least moderate severity (YBOCS score of 16 or above). Exclusion Criteria: subjects with comorbid psychiatric disorders (except depression - HAM-D ) or history of drug abuse significant head injury, or of any neurosurgical procedure pregnant women patients with metal implants or illnesses that prevent attendance to sessions patients with a history of seizure or bearing pacemakers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Transcranial Magnetic Stimulation<br>Actual transcranial magnetic stimulation of supplementary motor areas bilaterally. | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* rTMS was administered by means of a NEURO-MS (NEUROSOFT LTD®, Russia) with a focal 8-shaped 70 mm coil. Stimulation parameters were 1-Hz, 20-min trains (1200 pulses/day) at 100% of resting MT, once a day, 5 days a week, for 2 weeks.<br>* Other names: Neuro-MS Transcranial Magnetic Stimulator;|
| Sham Comparator: Sham Transcranial Magnetic Stimulation<br>Sham transcranial magnetic stimulation over the supplementary motor areas. | Device: Sham repetitive transcranial magnetic stimulation<br>* The sham treatment was performed using the Neurosoft ® sham coil. A metal plate placed inside this coil prevents the magnetic field from stimulating the cortex. This coil looks and sounds like an active coil.<br>* Other names: Neurosoft sham coil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Y-BOCS scale scores relative to baseline | Y-BOCS: Yale-Brown Obsessive-Compulsive Scale | assessments were at baseline, at 2 weeks and at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive Compulsive Disorder, Transcranial Magnetic Stimulation, Treatment