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

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

Study Overview

• Status: Unknown
• Conditions: Aphasia

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In-patients from Neurology departments of the First Affiliated Hospital, Zhejiang University

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Healthy controls
Aphasia; Post stroke aphasia patients without any additional interventions for research purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: March 18, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: stroke; DTI; aphasia; resting-state
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: HRMRI- aphasia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No