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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Joaquim Brasil-Neto, University of Brasilia

ClinicalTrials.gov Identifier:

NCT01540305

First received: February 15, 2012

Last updated: February 27, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 15, 2012

Last Updated Date

February 27, 2012

Start Date ^ICMJE

May 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in Y-BOCS scale scores relative to baseline [ Time Frame: assessments were at baseline, at 2 weeks and at 3 months ] [ Designated as safety issue: No ]

Y-BOCS: Yale-Brown Obsessive-Compulsive Scale

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01540305 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Obsessive Compulsive Disorder

Intervention ^ICMJE

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.

Other Name: Neuro-MS Transcranial Magnetic Stimulator
Device: Sham repetitive transcranial magnetic stimulation
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.

Other Name: Neurosoft sham coil

Study Arm (s)

Active Comparator: Transcranial Magnetic Stimulation
Actual transcranial magnetic stimulation of supplementary motor areas bilaterally.

Intervention: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham Comparator: Sham Transcranial Magnetic Stimulation
Sham transcranial magnetic stimulation over the supplementary motor areas.

Intervention: Device: Sham repetitive transcranial magnetic stimulation

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01540305

Other Study ID Numbers ^ICMJE

49/09

Has Data Monitoring Committee

Responsible Party

Joaquim Brasil-Neto, University of Brasilia

Study Sponsor ^ICMJE

University of Brasilia

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Joaquim Brasil-Neto, MD, PhD

Universidade de Brasília

Information Provided By

University of Brasilia

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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