Repetitive Transcranial Magnetic Stimulation for Treating Depression: A Functional Magnetic Resonance Imaging Study
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|ClinicalTrials.gov Identifier: NCT01162382|
Recruitment Status : Suspended (Protocol currently undergoing changes. Will be relisted at later date.)
First Posted : July 14, 2010
Last Update Posted : March 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Transcranial Magnetic Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder: A Functional Connectivity Magnetic Resonance Imaging (fcMRI) Study|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||June 2013|
Experimental: Transcranial Magnetic Stimulation
Open-label transcranial magnetic stimulation
Device: Transcranial Magnetic Stimulation
Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.
Other Name: Magstim Rapid stimulator
- Hamilton Depression Rating Scale-24 point version (HDRS-24) [ Time Frame: At study entry and within 2 days of exiting 4 weeks of rTMS treatment ]HDRS-24 will be used to measure response to rTMS treatment. A 50% decrease in HDRS-24 score will indicate treatment response; HDRS-24 < 10 will indicate remission.
- fCMRI results [ Time Frame: At study entry and within 2 days of exiting 4 weeks of rTMS treatment ]Imaging studies will be compared to determine if any changes in functional connectivity can be correlated with treatment response.
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): NCT01162382
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Jose Garcia, MD||Washington University School of Medicine|