Language Functional Reorganization in Subcortical Infarction Patients (NCT03668132) | Clinical Trial Compass
CompletedNot Applicable
Language Functional Reorganization in Subcortical Infarction Patients
China80 participantsStarted 2016-01-19
Plain-language summary
Post stroke aphasia (PSA) is one of the most frequently happened deficiency of stoke, affecting speaking,comprehension, writing and reading of language. Generally, PSA is commonly seen in cortical damage, but in recent years it has been found that subcortical injury is also an important cause of PSA, which is called subcortical aphasia. Using fMRI technology, the investigators aim to investigate the language function of patients with subcortical cerebral infarction at different stages of recovery , and explored the mechanism of post-injury language reorganization in the brain.
The investigators recruited 60 first-episode acute cerebral infarction patients with one-side lesion in subcortical white matter (40 with left injury and 20with right injury) and 20 health volunteers. All participants are right-handed, and screened with MMSE, HAMD and HAMA to exclude cases of psychosis, post-stroke dementia and depression. Each participant was arranged to have three test sessions at different stages after the infarction (T1:within 3 days after onset of the stroke ; T2:28 ±3days after onset; T3: 90±3days after onset), with fMRI and Western aphasia battery (WAB) in each session.
The purpose of this study is to explore the pathogenesis of subcortical aphasia, and to understand the dynamic reorganization of language network during the recovery of language function.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The first stroke of the left single subcortical areas, within 72hours.
* Primary school or higher level,aged between 18-75, native language Chinese
* According to the commonly used eye chart examination, the corrected visual acuity is more than 1.0.
* According to the Edinburgh Handedness Questionnaire (EHQ) as the right handed.
* The language function was normal before the onset. After the onset, the language function was mildly to moderately impaired with Western Aphasia Battery (WAB) ( Aphasia Quotient (AQ) between in 60 to 88).
* The patient cooperate with the examination, they and their guardian signed the informed consent
Exclusion Criteria:
* History of organic diseases of the nervous system and history of craniocerebral trauma.
* History of epilepsy and psychosis.
* History of material dependence.
* Decompensation of important organ function.
* Hamilton Depression Scale(HAMD )\>8 points.
* Hamilton Anxiety Scale(HAMA )\>7 points.
* The Mini-Mental State Examination (MMSE)score \<20 points.
* Pregnant women and breast-feeding women.
* Contraindication of MRI scanning.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A change of outcome measure: the Chinese version of Western Aphasia Battery(WAB)
Timeframe: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.
Trial details
NCT IDNCT03668132
SponsorGuangzhou General Hospital of Guangzhou Military Command