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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Manitoba
Sponsor:
Collaborator:
Manitoba Medical Service Foundation
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT02018185
First received: December 10, 2013
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Obsessive Compulsive Disorder
Device: Transcranial Magnetic Stimulation
Device: Sham Transcranial Magnetic Stimulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Change in obsessive and compulsive symptom severity (Yale-Brown Obsessive Compulsive Scale) [ Time Frame: Four recordings: baseline; after two weeks of rTMS; after four weeks of rTMS; one month following the last session of rTMS ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018185

Locations
Canada, Manitoba
St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada, R3P2B4
Contact: Faranak Nasseri, MD    2042372975    rtms.ocd@gmail.com   
Contact: Benjamin Meek, BSc MA    2042372677      
Principal Investigator: Mandana Modirrousta, MD PhD FRCPC         
Sponsors and Collaborators
University of Manitoba
Manitoba Medical Service Foundation
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02018185     History of Changes
Other Study ID Numbers: B2013:144
Study First Received: December 10, 2013
Last Updated: January 31, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on August 01, 2014