AphasiaNCT03475745
The Usage of High-resolution Magnetic Resonance Imaging in Patients With Post-stroke Aphasia for Predicting the Outcome
An observational study of Aphasia, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Combined analysis of functional and structural language network changes may be a good model for predicting language outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphasia
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2017to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In-patients from Neurology departments of the First Affiliated Hospital, Zhejiang University
Who may be able to join
- Healthy right-handed native Chinese speakers with more than 6-year education are recruited as healthy controls.
Who cannot join
- Not right-handed;
- Any use of psychoactive drugs;
- Less than 6-year education;
- Not suitable for MRI scan.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang
About this study
Combined analysis of functional and structural language network changes may be a good model for predicting language outcome.
Read the 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..
- Conditions
- Aphasia
- Keywords
- resting-state, DTI, aphasia, stroke
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aphasia | Post stroke aphasia patients without any additional interventions for research purposes. | |
| Control | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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,
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start20 Nov 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benyan Luo, Ph.D, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475745
- Sponsor's protocol ID
- HRMRI- aphasia
- Status last verified
- Nov 2017
- First submitted
- 18 Mar 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usage of High-resolution Magnetic Resonance Imaging in Patients With Post-stroke Aphasia for Predicting the Outcome
- ClinicalTrials.gov ID
- NCT03475745
- Acronym / sponsor ID
- HRMRI- aphasia
- Conditions
- Aphasia
- Keywords
- resting-state, DTI, aphasia, stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aphasia | – | –Post stroke aphasia patients without any additional interventions for research purposes. |
| Control | – | –Healthy controls |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In-patients from Neurology departments of the First Affiliated Hospital, Zhejiang University
Key inclusion criteria (1 listed)
- Healthy right-handed native Chinese speakers with more than 6-year education are recruited as healthy controls.
Key exclusion criteria (4 listed)
- Not right-handed;
- Any use of psychoactive drugs;
- Less than 6-year education;
- Not suitable for MRI scan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Aphasia Battery of Chinese, ABC
Time frame: 3 months
White matter Integrity
Time frame: 3 months
Brain response change
Time frame: 3 months
Resting state functional connectivity changes
Time frame: 6 months
Aphasia Battery of Chinese, ABC
Time frame: 6 months
White matter Integrity
Time frame: 6 months
Brain response change
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benyan Luo, Ph.D principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphasia, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting state functional connectivity changes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.