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Completed

NCT Number: NCT05427422

Stroke Recovery Research Based on EEG-fMRI

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.

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Key information

Conditions

Motor Neuropathy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Neuritis Neuromuscular Diseases Peripheral Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xi'an Daxing Hospital

Xi’an, Shanxi, 710016, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Fugl-Meyer scores (T0)

    Time frame: 7-14 days since stroke

    a scale widely used to evaluate one's motor impairment

  2. Fugl-Meyer scores (T1)

    Time frame: 6 weeks since stroke

    a scale widely used to evaluate one's motor impairment

  3. Fugl-Meyer scores (T2)

    Time frame: 12 weeks since stroke

    a scale widely used to evaluate one's motor impairment

  4. Fugl-Meyer scores (T3)

    Time frame: 72 weeks since stroke

    a scale widely used to evaluate one's motor impairment

Secondary outcomes

  1. Neuroimage features based on EEG-fMRI (T0)

    Time frame: 7-14 days since stroke

    Neuroimage features extracted from EEG-fMRI data

  2. Neuroimage features based on EEG-fMRI (T1)

    Time frame: 6 weeks since stroke

    Neuroimage features extracted from EEG-fMRI data

  3. Neuroimage features based on EEG-fMRI (T2)

    Time frame: 12 weeks since stroke

    Neuroimage features extracted from EEG-fMRI data

  4. Neuroimage features based on EEG-fMRI (T3)

    Time frame: 72 weeks since stroke

    Neuroimage features extracted from EEG-fMRI data

Sponsors and collaborators

Lead sponsor

Xi'an Jiaotong University

Other

Collaborators

  • Xian Daxing Hospital

Registry information

Official study title

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

Acronym: EEG-fMRI

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 22, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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