Clinical trial NCT03475745: The Usage of High-resolution Magnetic Resonance Imaging in Patients With Post-stroke Aphasia for Predicting the Outcome
Official title: The Usage of High-resolution Magnetic Resonance Imaging in Patients With Post-stroke Aphasia for Predicting the Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aphasia
Keywords: resting-state
DTI
aphasia
stroke
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-patients from Neurology departments of the First Affiliated Hospital, 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..

Eligibility criteria: 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.

Primary outcomes:
measure: Resting state functional connectivity changes
timeFrame: 3 months
Secondary outcomes:
measure: Aphasia Battery of Chinese, ABC
timeFrame: 3 months
measure: White matter Integrity
timeFrame: 3 months
measure: Brain response change
timeFrame: 3 months
measure: Resting state functional connectivity changes
timeFrame: 6 months
measure: Aphasia Battery of Chinese, ABC
timeFrame: 6 months
measure: White matter Integrity
timeFrame: 6 months
measure: Brain response change
timeFrame: 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital, Zhejiang University
name: Benyan Luo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: