Cerebral Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation by Neuroimaging Analysis

Study Overview
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Brief Summary
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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.

Official Title
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Study of Cerebral Structural and Functional Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation (rTMS) Using the Method of Neuroimaging Brain Network Analysis

Conditions
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Stroke

Intervention / Treatment
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* Device: real Repetitive Transcranial Magnetic Stimulation
* Device: sham Repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stroke patients within 1 week after onset with unilateral cerebral subcortex lesion in the middle cerebral artery territory detected by diffusion weighted image, right-handed, without memory loss or intelligence disorder, never suffered stroke before. Exclusion Criteria: direct damage to the cerebral cortex, a history of cerebral vessel disease, tendency to hemorrhage or existed brain hemorrhage, epilepsy or other mental disorders, any MRI contraindications.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS treatment group<br>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<br>* 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.<br>|
| Sham Comparator: sham group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Stroke Scale (NIHSS) | The investigators use National Institutes of Health Stroke Scale (NIHSS) to evaluate the participants' neural deficit after stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. Higher NIHSS scores mean a worse outcome. | Change from Baseline NIHSS at 1 month after real rTMS/sham rTMS | 
| Barthel Index (BI) | The investigators use Barthel Index (BI) to evaluate the participants' activities of daily living after stroke. The BI consists of 10 questions that relate to degree of independence with activities of daily living, including toileting, bathing, eating, dressing, continence, transfers, and ambulation. The BI score is calculated by summing the response value to each of the 10 questions. The BI score ranges from 0 to 100. A patient scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities. A higher score is associated with a better outcome. | Change from Baseline BI at 1 month after real rTMS/sham rTMS | 
| Fugl-Meyer Assessment Upper Limb (FMA-UL) | The investigators use Fugl-Meyer assessment Upper Limb (FMA-UL) to evaluate the participants' motor function of upper limb. The FMA-UL is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximum score of FMA-UL is 66 and the minimum score is 0. Higher scores mean a better outcome. | Change from Baseline FMA at 1 month after real rTMS/sham rTMS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Connectivity Map (FC Map) | 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. | Change from Baseline z-FC maps at 1 month after real rTMS/sham rTMS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic stroke, Functional magnetic resonance imaging (fMRI), Repetitive transcranial magnetic stimulation (rTMS), Brain Reorganization