The Effect of Venlafaxine on Language Function in Patients With Subcortical Aphasia: A fMRI Study (NCT03588572) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Venlafaxine on Language Function in Patients With Subcortical Aphasia: A fMRI Study
China43 participantsStarted 2018-08-01
Plain-language summary
Previous studies have demonstrated that venlafaxine significantly improves the language function of healthy subjects and increase of fMRI activation in cortical language area. This study was designed to investigate the relationship between venlafaxine on the cortical language functional reorganization and clinical language improvements in the stroke patients with subcortical aphasia.
It is a randomized, controlled, single-blind, longitudinal trial which has approved by the ethics committee of Guangzhou General Hospital of Guangzhou Military Command, and all patients and their guardian should sign an informed consent. The patients will divide into the venlafaxine group and the control group according to the principle of randomization (random number table). The patients in the venlafaxine group begin to take a venlafaxine hydrochloride capsule after enrollment ( each containing venlafaxine 75mg), qd, until 4 weeks after randomization, and the control group do not. Assessments of language functional behavior and examines of functional magnetic resonance imaging (fMRI) should be performed on the first days (V1), 28±3 days (V2) and 90±3 days (V3) after randomization.
Through all this procession, we expect improve the language function of participants in experiment and clarify its mechanism,the research may help develop a new treatment for other patients with similar conditions.
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.
* Dysphagia(difficult to take capsules).
* A history of allergens in component of venlafaxine.
* Pregnant women and breast-feeding women.
* Contraindication of MRI.
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 on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.
Trial details
NCT IDNCT03588572
SponsorGuangzhou General Hospital of Guangzhou Military Command