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Study of Magnetic Brain Stimulation in Treatment of Obsessive Compulsive Disorder (rTMS)

Primary Purpose

Obsessive Compulsive Disorder

Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sham Transcranial Magnetic Stimulation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed obsessive compulsive disorder
  • Not currently receiving cognitive behavioural therapy
  • Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI)

Exclusion Criteria:

  • History of psychotic episodes
  • History of neurological illness
  • Previous head injury
  • Active alcohol or substance abuse
  • History of seizure disorders
  • Currently pregnant

Sites / Locations

  • St. Boniface Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Transcranial Magnetic Stimulation

Sham rTMS

Arm Description

Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation

Outcomes

Primary Outcome Measures

Change in obsessive and compulsive symptom severity (Yale-Brown Obsessive Compulsive Scale)

Secondary Outcome Measures

Full Information

First Posted
December 10, 2013
Last Updated
March 22, 2021
Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02018185
Brief Title
Study of Magnetic Brain Stimulation in Treatment of Obsessive Compulsive Disorder
Acronym
rTMS
Official Title
The Efficacy of Deep Repetitive Transcranial Magnetic Stimulation in Treatment of Obsessive Compulsive Disorder, a Double Blind Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Suspended
Why Stopped
Recruitment has been suspended in order to perform interim data analysis.
Study Start Date
January 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In a preliminary pilot study, the investigators tested the efficacy of rTMS over the medial prefrontal cortex in symptom profiles of obsessive compulsive disorder (OCD) patients. This study revealed considerable benefit in using rTMS for the treatment of OCD. In the current proposal, in a randomized clinical trial, the investigators aim to further evaluate the efficacy of rTMS in OCD in a larger sample size and for a longer period. Studies into the efficacy of rTMS in other psychiatric disorders such as depression have consistently shown that extension of the treatment to four weeks significantly increased the effect size. In the pilot study, the investigators applied rTMS for only two weeks. Although all patients consistently showed improvement in their symptoms, none of them showed complete remission of their OCD. Here, the investigators hypothesize that longer duration of rTMS treatment will have greater benefit in OCD symptom reduction.
Detailed Description
The purpose of study is to examine the efficacy of rTMS over the medial prefrontal cortex in the treatment of OCD. rTMS will be provided to OCD patients in a randomized double blind controlled setting, and the investigators hypothesize that in this setting the treatment group would still show significant improvement in OCD symptoms as compared to the sham group. rTMS will be applied for four weeks on OCD patients and the investigators will assess improvement after four weeks of rTMS. The investigators hypothesize that patients will show significantly greater improvement after four weeks of rTMS vs. two weeks of rTMS.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
Transcranial Magnetic Stimulation
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham Transcranial Magnetic Stimulation
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
A non-invasive method for brain stimulation
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Magnetic Stimulation
Intervention Description
Sham stimulation of the brain.
Primary Outcome Measure Information:
Title
Change in obsessive and compulsive symptom severity (Yale-Brown Obsessive Compulsive Scale)
Time Frame
Recordings: baseline; after two weeks of rTMS; after four weeks of rTMS; monthly for three months following the last session of rTMS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed obsessive compulsive disorder Not currently receiving cognitive behavioural therapy Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI) Exclusion Criteria: History of psychotic episodes History of neurological illness Previous head injury Active alcohol or substance abuse History of seizure disorders Currently pregnant
Facility Information:
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3P2B4
Country
Canada

12. IPD Sharing Statement

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Study of Magnetic Brain Stimulation in Treatment of Obsessive Compulsive Disorder

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