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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
Sponsor:
Collaborators:
Chinese Academy of Sciences
University of Pennsylvania
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
The study aimed to figure out brain structural and functional reorganization evidence after repetitive transcranial magnetic stimulation through the method of neuroimaging brain network analysis, such as resting-state functional magnetic resonance imaging and diffusion tensor imaging.

Condition or disease Intervention/treatment Phase
Stroke Device: real Repetitive Transcranial Magnetic Stimulation Device: sham Repetitive Transcranial Magnetic Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. stroke patients within 1 week after onset with unilateral cerebral subcortex lesion in the middle cerebral artery territory detected by diffusion weighted image,
  2. right-handed,
  3. without memory loss or intelligence disorder,
  4. never suffered stroke before.

Exclusion Criteria:

  1. direct damage to the cerebral cortex,
  2. a history of cerebral vessel disease,
  3. tendency to hemorrhage or existed brain hemorrhage,
  4. epilepsy or other mental disorders,
  5. any MRI contraindications.

Information from the National Library of Medicine

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): NCT03163758


Contacts
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Contact: Weihong Zhang, Ph.D,MD +86-10-6915-9581 zhangweihong@pumch.cn
Contact: Yuzhou Guan, Ph.D,MD +86-10-6915-6371 guanyz001@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Weihong Zhang, Ph.D,MD    +86-10-6915-9581    zhangweihong@pumch.cn   
Contact: Yuzhou Guan, Ph.D,MD    +86-10-6915-6371    guanyz001@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Chinese Academy of Sciences
University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03163758     History of Changes
Other Study ID Numbers: NNSFC-81271545
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: December 2016

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peking Union Medical College Hospital:
Ischemic stroke
Functional magnetic resonance imaging (fMRI)
Repetitive transcranial magnetic stimulation (rTMS)
Brain Reorganization

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases