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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163758
• Other study ID #: NNSFC-81271545
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2018

Study information

• Verified date: June 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Chinese Academy of Sciences, University of Pennsylvania

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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