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Clinical Trials/NCT03475745
NCT03475745UnknownNot Applicable

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

First Affiliated Hospital of Zhejiang University1 site in 1 country50 target enrollmentStarted: November 20, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Resting state functional connectivity changes

Study Overview

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:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Resting state functional connectivity changes

Time Frame: 3 months

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

Secondary Outcomes

  • Resting state functional connectivity changes(6 months)
  • White matter Integrity(6 months)
  • Brain response change(6 months)
  • Aphasia Battery of Chinese, ABC(6 months)

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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