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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05427422
Other study ID # Stroke01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2022
Est. completion date January 30, 2024

Study information

Verified date February 2024
Source Health Science Center of Xi'an Jiaotong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date January 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Xi'an Daxing Hospital Xi'an Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Health Science Center of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fugl-Meyer scores (T0) a scale widely used to evaluate one's motor impairment 7-14 days since stroke
Primary Fugl-Meyer scores (T1) a scale widely used to evaluate one's motor impairment 6 weeks since stroke
Primary Fugl-Meyer scores (T2) a scale widely used to evaluate one's motor impairment 12 weeks since stroke
Primary Fugl-Meyer scores (T3) a scale widely used to evaluate one's motor impairment 72 weeks since stroke
Secondary Neuroimage features based on EEG-fMRI (T0) Neuroimage features extracted from EEG-fMRI data 7-14 days since stroke
Secondary Neuroimage features based on EEG-fMRI (T1) Neuroimage features extracted from EEG-fMRI data 6 weeks since stroke
Secondary Neuroimage features based on EEG-fMRI (T2) Neuroimage features extracted from EEG-fMRI data 12 weeks since stroke
Secondary Neuroimage features based on EEG-fMRI (T3) Neuroimage features extracted from EEG-fMRI data 72 weeks since stroke
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