The Usage of High-resolution Magnetic Resonance Imaging in Patients With Post-stroke Aphasia for Predicting the Outcome

• Conditions: Aphasia

• Registration Number: NCT03475745
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

Combined analysis of functional and structural language network changes may be a good model for predicting language outcome.

Detailed Description

Background \& objectives:

Language impairment after aphasic stroke is both common and debilitating. However the mechanisms of language recovery after aphasic stroke is not fully understood. Investigators plan to detect the changes of functional and structural language networks after aphasic stroke by high-resolution MRI.Then Combined analyse functional and structural language network changes, establishing a prediction model for language outcome.

Methods:

The proposed study is a observational trial that will include 50 patients diagnosed with post stroke aphasia from the neurology clinics at The First Affiliated Hospital, Zhejiang University. Aphasia battery of Chinese(ABC) and functional magnetic resonance imaging (MRI) will be performed at acute(\~2weeks),subacute(3 months) and chronic phase(6months). Only routine drug therapy will be used.

Relevance:

Currently there is little known about the recovery mechanisms of post-stroke aphasia.The proposed study intends to analyse functional and structural language network changes by high resolution MRI, which may reveal the potential recovery mechanism underlying post stroke aphasia..

Study Timeline

• Status Verified: 2017-11
• Study Start: 2017-11-20
• Study First Submitted: 2018-03-18
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-23
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19
• Primary Completion: 2019-12-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy right-handed native Chinese speakers with more than 6-year education are recruited as healthy controls.

Exclusion Criteria

• Not right-handed;
• Any use of psychoactive drugs;
• Less than 6-year education;
• Not suitable for MRI scan.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resting state functional connectivity changes	3 months	The study uses resting state functional MRI(rs-fMRI) to measure changes of functional connectivity across regions after a spontaneous recovery.

Secondary Outcome Measures

Name	Time	Method
White matter Integrity	6 months	The study uses Diffusion tensor imaging and tracking (DTI) to measure changes of the Integrity of white matter after a spontaneous recovery.
Brain response change	6 months	The study uses task functional MRI (fMRI) to measure the brain response changes during the task after a spontaneous recovery.
Aphasia Battery of Chinese, ABC	6 months	ABC, the Chinese standardized adaptation of the Western Aphasia Battery, indicates the patient's ability of spontaneous speech, auditory comprehension, repetition, naming, reading,
Resting state functional connectivity changes	6 months	The study uses resting state functional MRI(rs-fMRI) to measure changes of functional connectivity across regions after a spontaneous recovery.

Trial Locations

Locations (1)

The First Affiliated Hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China