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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014