Stroke Recovery Research Based on EEG-fMRI (EEG-fMRI)

Motor Recovery of Stroke Patients Based on Electroencephalogram-functional Magnetic Resonance Imaging

This study is aimed to investigate the post-stroke motor recovery of patients with ischemic stroke based on their neural features extracted from EEG-fMRI data.

Study Overview

• Status: Completed
• Conditions: Motor Neuropathy
• Intervention / Treatment: Diagnostic test: MRI recording; Diagnostic test: EEG recording

Detailed Description

A group of patients with ischemic stroke and age/gender matched healthy controls would be enrolled in this study. Their features of neural activities based on EEG-fMRI fusion scan would be extracted to investigate the mechanisms of motor recovery after stroke. Particularly, the correlations of their features of neural networks or local activities to their motor function (defined as their Fugl-Meyer scores) at enrollment and their recovery time courses consisted of Fugl-Meyer scores in follow-up time points. Data of T1 structural, DSI fiber image and pure EEG (without MRI) would also be collected along with EEG-fMRI fusion data.

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710016
      • Xi'an Daxing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

AA population with motor impairment induced by first-ever stroke in a specific duration (7-14 days after stroke attack, i.e., early subacute stage) would be enrolled to investigate the mechanisms of post-stroke recovery of motor function.

Description

Inclusion Criteria:

• Age above 18 and below 75 years
• Motor impairment in National Institutes of Health Stroke Scale
• 7-14 days since stroke attack
• First-ever ischemic stroke

Exclusion Criteria:

• Motor impairment induced by non-stroke aetiology
• Claustrophobia; recognition disorder
• History of other severe central nervous system diseases
• Any signs unfit for MRI/EEG scan

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Control; Age/sex matched healthy subjects enrolled to compare with group of patients.	Diagnostic test: MRI recording; MRI imaging was performed using a 3 Tesla Siemens Prisma system with a 64-channel head/neck coil (Siemens Medical Systems, Erlangen, Germany). The MRI protocols included as follows: (i) Magnetization-Prepared 2 Rapid Acquisition Gradient Echoes: TR/TE/ TI1/TI2 = 5000/2.98/700/2500 ms, voxel size = 1.0 × 1.0 × 1.0 mm3, FOV = 256 × 240 × 176 mm3; (ii)Gradient-echo EPI: TR 720 ms, TE 33.1 ms, flip angle 52 deg, FOV 208x180 mm, Matrix 104x90, Slice thickness 2.0 mm; 72 slices; 2.0 mm isotropic voxels, Multiband factor 8, Echo spacing 0.58 ms, BW 2290 Hz/Px; (iii) DSI : TR/TE = 3300/73 ms, FOV = 220 × 220 × 60 mm3, voxel size = 2 × 2 × 2 mm3, 128 diffusion direction, b-max = 3000 sec/mm2, AT = 7:22 min); (iv) T2-weighted fluid-attenuated inversion recovery: TR/TE = 9000/84 ms, FOV = 270 × 320 × 22 mm2, voxel size = 0.72 × 0.72 × 6.6 mm3.; Diagnostic test: EEG recording; EEG was performed using a BrainAmp MR 32 amplifier (BrainProducts GmbH, München, Germany). The EEG protocols included as follows: (i) EEG-fMRI fusion: Sampling rate: 5000 Hz, low cut off-high cut off: DC-1000Hz;(2) EEG-fMRI fusion: Sampling rate: 1000 Hz, low cut off-high cut off: DC-1000Hz. In (i) an ECG channel would be used to collect artifact of pulse and not used in (ii).
High Recovery; Effective recovery rate defined as difference between Fugl-meyer scores in the 6 weeks after stroke onset (eF) and in the enrollment (sF) normalized by (total score-sf) would be used to indicate the recovery Level of a patients, i.e., (eF-sF)/ (total score-sf). A previously reported recovery rate, i.e., proportional recovery((eF-sF)/(total score-sf)=0.7) was chosen as a standard of a high recovery. Patients with effective recovery rate higher than 0.7 at the T1 time point (6 weeks after stroke onset) would be assigned to group with high recovery rate	Diagnostic test: MRI recording; MRI imaging was performed using a 3 Tesla Siemens Prisma system with a 64-channel head/neck coil (Siemens Medical Systems, Erlangen, Germany). The MRI protocols included as follows: (i) Magnetization-Prepared 2 Rapid Acquisition Gradient Echoes: TR/TE/ TI1/TI2 = 5000/2.98/700/2500 ms, voxel size = 1.0 × 1.0 × 1.0 mm3, FOV = 256 × 240 × 176 mm3; (ii)Gradient-echo EPI: TR 720 ms, TE 33.1 ms, flip angle 52 deg, FOV 208x180 mm, Matrix 104x90, Slice thickness 2.0 mm; 72 slices; 2.0 mm isotropic voxels, Multiband factor 8, Echo spacing 0.58 ms, BW 2290 Hz/Px; (iii) DSI : TR/TE = 3300/73 ms, FOV = 220 × 220 × 60 mm3, voxel size = 2 × 2 × 2 mm3, 128 diffusion direction, b-max = 3000 sec/mm2, AT = 7:22 min); (iv) T2-weighted fluid-attenuated inversion recovery: TR/TE = 9000/84 ms, FOV = 270 × 320 × 22 mm2, voxel size = 0.72 × 0.72 × 6.6 mm3.; Diagnostic test: EEG recording; EEG was performed using a BrainAmp MR 32 amplifier (BrainProducts GmbH, München, Germany). The EEG protocols included as follows: (i) EEG-fMRI fusion: Sampling rate: 5000 Hz, low cut off-high cut off: DC-1000Hz;(2) EEG-fMRI fusion: Sampling rate: 1000 Hz, low cut off-high cut off: DC-1000Hz. In (i) an ECG channel would be used to collect artifact of pulse and not used in (ii).
Low Recovery; The Low Recovery group indicates that patients with effective recovery rate lower than 0.7	Diagnostic test: MRI recording; MRI imaging was performed using a 3 Tesla Siemens Prisma system with a 64-channel head/neck coil (Siemens Medical Systems, Erlangen, Germany). The MRI protocols included as follows: (i) Magnetization-Prepared 2 Rapid Acquisition Gradient Echoes: TR/TE/ TI1/TI2 = 5000/2.98/700/2500 ms, voxel size = 1.0 × 1.0 × 1.0 mm3, FOV = 256 × 240 × 176 mm3; (ii)Gradient-echo EPI: TR 720 ms, TE 33.1 ms, flip angle 52 deg, FOV 208x180 mm, Matrix 104x90, Slice thickness 2.0 mm; 72 slices; 2.0 mm isotropic voxels, Multiband factor 8, Echo spacing 0.58 ms, BW 2290 Hz/Px; (iii) DSI : TR/TE = 3300/73 ms, FOV = 220 × 220 × 60 mm3, voxel size = 2 × 2 × 2 mm3, 128 diffusion direction, b-max = 3000 sec/mm2, AT = 7:22 min); (iv) T2-weighted fluid-attenuated inversion recovery: TR/TE = 9000/84 ms, FOV = 270 × 320 × 22 mm2, voxel size = 0.72 × 0.72 × 6.6 mm3.; Diagnostic test: EEG recording; EEG was performed using a BrainAmp MR 32 amplifier (BrainProducts GmbH, München, Germany). The EEG protocols included as follows: (i) EEG-fMRI fusion: Sampling rate: 5000 Hz, low cut off-high cut off: DC-1000Hz;(2) EEG-fMRI fusion: Sampling rate: 1000 Hz, low cut off-high cut off: DC-1000Hz. In (i) an ECG channel would be used to collect artifact of pulse and not used in (ii).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer scores (T0)	a scale widely used to evaluate one's motor impairment	7-14 days since stroke
Fugl-Meyer scores (T1)	a scale widely used to evaluate one's motor impairment	6 weeks since stroke
Fugl-Meyer scores (T2)	a scale widely used to evaluate one's motor impairment	12 weeks since stroke
Fugl-Meyer scores (T3)	a scale widely used to evaluate one's motor impairment	72 weeks since stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroimage features based on EEG-fMRI (T0)	Neuroimage features extracted from EEG-fMRI data	7-14 days since stroke
Neuroimage features based on EEG-fMRI (T1)	Neuroimage features extracted from EEG-fMRI data	6 weeks since stroke
Neuroimage features based on EEG-fMRI (T2)	Neuroimage features extracted from EEG-fMRI data	12 weeks since stroke
Neuroimage features based on EEG-fMRI (T3)	Neuroimage features extracted from EEG-fMRI data	72 weeks since stroke

Collaborators and Investigators

• Sponsor: Health Science Center of Xi'an Jiaotong University
• Collaborators: Xian Daxing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: ischemic stroke; neural plasticity; motor function recovery; EEG-fMRI
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Stroke01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No