rTMS: Study of Magnetic Brain Stimulation in Treatment of Obsessive Compulsive Disorder

Sponsor
University of Manitoba (Other)
Overall Status
Suspended
CT.gov ID
NCT02018185
Collaborator
Manitoba Medical Service Foundation (Other)
30
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2
91
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Magnetic Stimulation
  • Device: Sham Transcranial Magnetic Stimulation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Deep Repetitive Transcranial Magnetic Stimulation in Treatment of Obsessive Compulsive Disorder, a Double Blind Randomized Clinical Trial
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation

Device: Transcranial Magnetic Stimulation
A non-invasive method for brain stimulation

Sham Comparator: Sham rTMS

Sham Transcranial Magnetic Stimulation

Device: Sham Transcranial Magnetic Stimulation
Sham stimulation of the brain.

Outcome Measures

Primary Outcome Measures

  1. Change in obsessive and compulsive symptom severity (Yale-Brown Obsessive Compulsive Scale) [Recordings: baseline; after two weeks of rTMS; after four weeks of rTMS; monthly for three months following the last session of rTMS]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Boniface Hospital Winnipeg Manitoba Canada R3P2B4

Sponsors and Collaborators

  • University of Manitoba
  • Manitoba Medical Service Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT02018185
Other Study ID Numbers:
  • B2013:144
First Posted:
Dec 23, 2013
Last Update Posted:
Mar 23, 2021
Last Verified:
Mar 1, 2021

Study Results

No Results Posted as of Mar 23, 2021