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

February 15, 2012
February 27, 2012
May 2011
September 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01540305 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy Study of Transcranial Magnetic Stimulation for Treatment of Obsessive-Compulsive Disorder
A Randomized Double-blind Trial of Repetitive Transcranial Magnetic Stimulation in Obsessive -Compulsive Disorder With Three Months Follow-up

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obsessive Compulsive Disorder
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01540305
49/09
No
Joaquim Brasil-Neto, University of Brasilia
University of Brasilia
Not Provided
Study Director: Joaquim Brasil-Neto, MD, PhD University of Brasilia
University of Brasilia
February 2012

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