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

Aphasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03475745
• Other study ID #: HRMRI- aphasia
• Status: Active, not recruiting
• First received: March 18, 2018
• Last updated: April 17, 2018
• Start date: November 20, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2017
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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..

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting state functional connectivity changes	The study uses resting state functional MRI(rs-fMRI) to measure changes of functional connectivity across regions after a spontaneous recovery.	3 months
Secondary	Aphasia Battery of Chinese, ABC	ABC, the Chinese standardized adaptation of the Western Aphasia Battery, indicates the patient's ability of spontaneous speech, auditory comprehension, repetition, naming, reading, writing.	3 months
Secondary	White matter Integrity	The study uses Diffusion tensor imaging and tracking (DTI) to measure changes of the Integrity of white matter after a spontaneous recovery.	3 months
Secondary	Brain response change	The study uses task functional MRI (fMRI) to measure the brain response changes during the task after a spontaneous recovery.	3 months
Secondary	Resting state functional connectivity changes	The study uses resting state functional MRI(rs-fMRI) to measure changes of functional connectivity across regions after a spontaneous recovery.	6 months
Secondary	Aphasia Battery of Chinese, ABC	ABC, the Chinese standardized adaptation of the Western Aphasia Battery, indicates the patient's ability of spontaneous speech, auditory comprehension, repetition, naming, reading,	6 months
Secondary	White matter Integrity	The study uses Diffusion tensor imaging and tracking (DTI) to measure changes of the Integrity of white matter after a spontaneous recovery.	6 months
Secondary	Brain response change	The study uses task functional MRI (fMRI) to measure the brain response changes during the task after a spontaneous recovery.	6 months