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Completed

NCT Number: NCT01540305

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

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.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Laboratory of Neurosciences and Behavior, Biology Institute, University of Brasília

Brasília, Federal District, 70000-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

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 names: Neuro-MS Transcranial Magnetic Stimulator

Sham repetitive transcranial magnetic stimulation

Device

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 names: Neurosoft sham coil

Primary outcomes

  1. Changes in Y-BOCS scale scores relative to baseline

    Time frame: assessments were at baseline, at 2 weeks and at 3 months

    Y-BOCS: Yale-Brown Obsessive-Compulsive Scale

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 28, 2012
Registry last updated
Feb 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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