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
  Purpose

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.


Condition Intervention Phase
Obsessive Compulsive Disorder
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Device: Sham repetitive transcranial magnetic stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Trial of Repetitive Transcranial Magnetic Stimulation in Obsessive -Compulsive Disorder With Three Months Follow-up

Resource links provided by NLM:


Further study details as provided by University of Brasilia:

Primary Outcome Measures:
  • 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


Enrollment: 22
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transcranial Magnetic Stimulation
Actual transcranial magnetic stimulation of supplementary motor areas bilaterally.
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
Sham Comparator: Sham Transcranial Magnetic Stimulation
Sham transcranial magnetic stimulation over the supplementary motor areas.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540305

Locations
Brazil
Laboratory of Neurosciences and Behavior, Biology Institute, University of Brasília
Brasília, DF, Brazil, 70000-000
Sponsors and Collaborators
University of Brasilia
Investigators
Study Director: Joaquim Brasil-Neto, MD, PhD University of Brasilia
  More Information

Publications:
Responsible Party: Joaquim Brasil-Neto, Dr., University of Brasilia
ClinicalTrials.gov Identifier: NCT01540305     History of Changes
Other Study ID Numbers: 49/09
Study First Received: February 15, 2012
Last Updated: February 27, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Brasilia:
Obsessive Compulsive Disorder
Transcranial Magnetic Stimulation
Treatment

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on April 17, 2014