NCT01540305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

February 15, 2012

Last Update Submit

February 27, 2012

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive DisorderTranscranial Magnetic StimulationTreatment

Outcome Measures

Primary Outcomes (1)

  • Changes in Y-BOCS scale scores relative to baseline

    Y-BOCS: Yale-Brown Obsessive-Compulsive Scale

    assessments were at baseline, at 2 weeks and at 3 months

Study Arms (2)

Transcranial Magnetic Stimulation

ACTIVE COMPARATOR

Actual transcranial magnetic stimulation of supplementary motor areas bilaterally.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham Transcranial Magnetic Stimulation

SHAM COMPARATOR

Sham transcranial magnetic stimulation over the supplementary motor areas.

Device: Sham repetitive transcranial magnetic stimulation

Interventions

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.

Also known as: Neuro-MS Transcranial Magnetic Stimulator
Transcranial Magnetic Stimulation
Sham repetitive transcranial magnetic stimulationDEVICE

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.

Also known as: Neurosoft sham coil
Sham Transcranial Magnetic Stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Brasília, Federal District, 70000-000, Brazil

Location

Related Publications (2)

  • Mantovani A, Simpson HB, Fallon BA, Rossi S, Lisanby SH. Randomized sham-controlled trial of repetitive transcranial magnetic stimulation in treatment-resistant obsessive-compulsive disorder. Int J Neuropsychopharmacol. 2010 Mar;13(2):217-27. doi: 10.1017/S1461145709990435. Epub 2009 Aug 20.

    PMID: 19691873BACKGROUND

  • Mantovani A, Lisanby SH, Pieraccini F, Ulivelli M, Castrogiovanni P, Rossi S. Repetitive transcranial magnetic stimulation (rTMS) in the treatment of obsessive-compulsive disorder (OCD) and Tourette's syndrome (TS). Int J Neuropsychopharmacol. 2006 Feb;9(1):95-100. doi: 10.1017/S1461145705005729. Epub 2005 Jun 28.

    PMID: 15982444BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Joaquim Brasil-Neto, MD, PhD

    University of Brasilia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 28, 2012

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

BR(1)