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

Phase 2

Completed

• Conditions: Obsessive Compulsive Disorder
• Interventions: Device: Sham repetitive transcranial magnetic stimulation; Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

• Registration Number: NCT01540305
• Lead Sponsor: University of Brasilia

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-02
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-27
• Last Update Submitted: 2012-02-27
• Study First Posted: 2012-02-28
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Transcranial Magnetic Stimulation	Sham repetitive transcranial magnetic stimulation	Sham transcranial magnetic stimulation over the supplementary motor areas.
Transcranial Magnetic Stimulation	Repetitive Transcranial Magnetic Stimulation (rTMS)	Actual transcranial magnetic stimulation of supplementary motor areas bilaterally.

Primary Outcome Measures

Name	Time	Method
Changes in Y-BOCS scale scores relative to baseline	assessments were at baseline, at 2 weeks and at 3 months	Y-BOCS: Yale-Brown Obsessive-Compulsive Scale

Trial Locations

Locations (1)

Laboratory of Neurosciences and Behavior, Biology Institute, University of Brasília; 🇧🇷 Brasília, DF, Brazil