Study of Magnetic Brain Stimulation in Treatment of Obsessive Compulsive Disorder (rTMS)
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|ClinicalTrials.gov Identifier: NCT02018185|
Recruitment Status : Suspended (Recruitment has been suspended in order to perform interim data analysis.)
First Posted : December 23, 2013
Last Update Posted : September 20, 2019
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|
|Obsessive Compulsive Disorder||Device: Transcranial Magnetic Stimulation Device: Sham Transcranial Magnetic Stimulation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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 :||January 2014|
|Actual Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018185
|St. Boniface Hospital|
|Winnipeg, Manitoba, Canada, R3P2B4|