Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
147 participants
OBSERVATIONAL
2022-06-30
2024-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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.
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
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.
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).
Healthy Control
Age/sex matched healthy subjects enrolled to compare with group of patients.
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.
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).
Interventions
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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.
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).
Eligibility Criteria
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Inclusion Criteria
* Motor impairment in National Institutes of Health Stroke Scale
* 7-14 days since stroke attack
* First-ever ischemic stroke
Exclusion Criteria
* Claustrophobia; recognition disorder
* History of other severe central nervous system diseases
* Any signs unfit for MRI/EEG scan
18 Years
75 Years
ALL
Yes
Sponsors
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Xian Daxing Hospital
UNKNOWN
Xi'an Jiaotong University
OTHER
Responsible Party
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Wentao Zeng
PhD candidate
Locations
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Xi'an Daxing Hospital
Xi’an, Shanxi, China
Countries
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Other Identifiers
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Stroke01
Identifier Type: -
Identifier Source: org_study_id
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