Cerebral Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation by Neuroimaging Analysis
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|ClinicalTrials.gov Identifier: NCT03163758|
Recruitment Status : Unknown
Verified December 2016 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : May 23, 2017
Last Update Posted : May 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: real Repetitive Transcranial Magnetic Stimulation Device: sham Repetitive Transcranial Magnetic Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Study of Cerebral Structural and Functional Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation (rTMS) Using the Method of Neuroimaging Brain Network Analysis|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: rTMS treatment group
The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.
Device: real Repetitive Transcranial Magnetic Stimulation
The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.
Sham Comparator: sham group
The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.
Device: sham Repetitive Transcranial Magnetic Stimulation
The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.
- National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: Change from Baseline NIHSS at 1 month after real rTMS/sham rTMS ]The investigators use NIHSS to evaluate the participants' motor function.
- Barthel Index (BI) [ Time Frame: Change from Baseline BI at 1 month after real rTMS/sham rTMS ]The investigators use BI to evaluate the participants' activities of daily living.
- Fugl-Meyer assessment (FMA) [ Time Frame: Change from Baseline FMA at 1 month after real rTMS/sham rTMS ]The investigators use FMA to evaluate the participants' motor function.
- functional connectivity (FC) [ Time Frame: Change from Baseline FC at 1 month after real rTMS/sham rTMS ]Functional Connectivity was examined using a seed-based voxel-wise correlation approach. The ipsilesional primary motor cortex (M1) was defined as the region of interest. Pearson's correlation analysis between the time course of the ipsilesional M1 and that of every voxel in the whole brain was computed for a map of correlation coefficients, which were Fisher's z-transformed and called as z-FC maps.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163758
|Contact: Weihong Zhang, Ph.D,MDemail@example.com|
|Contact: Yuzhou Guan, Ph.D,MDfirstname.lastname@example.org|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Weihong Zhang, Ph.D,MD +86-10-6915-9581 email@example.com|
|Contact: Yuzhou Guan, Ph.D,MD +86-10-6915-6371 firstname.lastname@example.org|