Study Stopped
Recruitment has been suspended in order to perform interim data analysis.
Study of Magnetic Brain Stimulation in Treatment of Obsessive Compulsive Disorder
rTMS
The Efficacy of Deep Repetitive Transcranial Magnetic Stimulation in Treatment of Obsessive Compulsive Disorder, a Double Blind Randomized Clinical Trial
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
December 23, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedMarch 23, 2021
March 1, 2021
4.9 years
December 10, 2013
March 22, 2021
Conditions
Outcome Measures
Primary Outcomes (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
Study Arms (2)
Transcranial Magnetic Stimulation
ACTIVE COMPARATORTranscranial Magnetic Stimulation
Sham rTMS
SHAM COMPARATORSham Transcranial Magnetic Stimulation
Interventions
A non-invasive method for brain stimulation
Eligibility Criteria
You may qualify if:
- Diagnosed obsessive compulsive disorder
- Not currently receiving cognitive behavioural therapy
- Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI)
You may not qualify if:
- History of psychotic episodes
- History of neurological illness
- Previous head injury
- Active alcohol or substance abuse
- History of seizure disorders
- Currently pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- Manitoba Medical Service Foundationcollaborator
Study Sites (1)
St. Boniface Hospital
Winnipeg, Manitoba, R3P2B4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2013
First Posted
December 23, 2013
Study Start
January 1, 2014
Primary Completion
December 1, 2018
Study Completion
August 1, 2021
Last Updated
March 23, 2021
Record last verified: 2021-03