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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: sham Repetitive Transcranial Magnetic Stimulation; Device: real Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT03163758
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-05-20
• Study First Posted: 2017-05-23
• Primary Completion: 2017-12
• Study Completion: 2018-12
• Results First Submitted: 2019-07-13
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-13
• Last Update Submitted: 2020-06-13
• Results First Posted: 2020-06-30
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham group	sham Repetitive Transcranial Magnetic Stimulation	The sham group received a 10-day sham repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.
rTMS treatment group	real Repetitive Transcranial Magnetic Stimulation	The rTMS treatment group received a 10-day real repetitive transcranial magnetic stimulation (rTMS) treatment beginning within 1 week after stroke onset.

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale (NIHSS)	Change from Baseline NIHSS at 1 month after real rTMS/sham rTMS	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.
Barthel Index (BI)	Change from Baseline BI at 1 month after real rTMS/sham rTMS	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.
Fugl-Meyer Assessment Upper Limb (FMA-UL)	Change from Baseline FMA at 1 month after real rTMS/sham rTMS	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.

Secondary Outcome Measures

Name	Time	Method
Functional Connectivity Map (FC Map)	Change from Baseline z-FC maps 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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China