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

Primary Purpose

Obsessive Compulsive Disorder

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham repetitive transcranial magnetic stimulation

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive Compulsive Disorder, Transcranial Magnetic Stimulation, Treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation

Arm Description

Actual transcranial magnetic stimulation of supplementary motor areas bilaterally.

Sham transcranial magnetic stimulation over the supplementary motor areas.

Outcomes

Primary Outcome Measures

Changes in Y-BOCS scale scores relative to baseline

Y-BOCS: Yale-Brown Obsessive-Compulsive Scale

Secondary Outcome Measures

Full Information

NCT ID

NCT01540305

First Posted

February 15, 2012

Last Updated

February 27, 2012

Sponsor

University of Brasilia

1. Study Identification

Unique Protocol Identification Number

NCT01540305

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Brasilia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive Disorder, Transcranial Magnetic Stimulation, Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transcranial Magnetic Stimulation

Arm Type

Active Comparator

Arm Description

Actual transcranial magnetic stimulation of supplementary motor areas bilaterally.

Arm Title

Sham Transcranial Magnetic Stimulation

Arm Type

Sham Comparator

Arm Description

Sham transcranial magnetic stimulation over the supplementary motor areas.

Intervention Type

Device

Intervention Name(s)

Repetitive Transcranial Magnetic Stimulation (rTMS)

Other Intervention Name(s)

Neuro-MS Transcranial Magnetic Stimulator

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham repetitive transcranial magnetic stimulation

Other Intervention Name(s)

Neurosoft sham coil

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in Y-BOCS scale scores relative to baseline

Description

Y-BOCS: Yale-Brown Obsessive-Compulsive Scale

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joaquim Brasil-Neto, MD, PhD

Organizational Affiliation

University of Brasilia

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Brasília

State/Province

ZIP/Postal Code

70000-000

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

19691873

Citation

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.

Results Reference

background

PubMed Identifier

15982444

Citation

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.

Results Reference

background

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

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