Stroke Recovery Research Based on EEG-fMRI

NCT05427422 | Completed

• 1 other identifier: Stroke01
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Motor Neuropathy

Keywords

motor function recovery; ischemic stroke; EEG-fMRI; neural plasticity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Neuroimage features based on EEG-fMRI (T0)

  7-14 days since stroke

• Neuroimage features based on EEG-fMRI (T1)

  6 weeks since stroke

• Neuroimage features based on EEG-fMRI (T2)

  12 weeks since stroke

• Neuroimage features based on EEG-fMRI (T3)

  72 weeks since stroke

Study Arms (3)

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; Diagnostic Test: EEG recording

Low Recovery

The Low Recovery group indicates that patients with effective recovery rate lower than 0.7

Diagnostic Test: MRI recording; Diagnostic Test: EEG recording

Healthy Control

Age/sex matched healthy subjects enrolled to compare with group of patients.

Diagnostic Test: MRI recording; Diagnostic Test: EEG recording

Interventions

MRI recording DIAGNOSTIC_TEST

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.

Healthy Control; High Recovery; Low Recovery

EEG recording DIAGNOSTIC_TEST

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; High Recovery; Low Recovery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xi'an Jiaotong University: lead
• Xian Daxing Hospital: collaborator

Study Sites (1)

Xi'an Daxing Hospital

Xi’an, Shanxi, 710016, China

Location

MeSH Terms

Conditions

Neuritis; Ischemic Stroke

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 22, 2022
• Study Start: June 30, 2022
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)