N/A
Completed N=43
The Effect of Venlafaxine on Language Function in Patients With Subcortical Aphasia: A fMRI Study
Subcortical Aphasia · Stroke
Source: ClinicalTrials.gov NCT03588572 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) — 78.16; 78.60; 88.24; 83.51 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) |
78.16; 78.60; 88.24; 83.51; 94.23; 88.55 | — |
| SECONDARY A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) |
5.31; 5.75; 9.31; 8.13; 12.69; 10.81 | — |
| SECONDARY A Change of Outcome Measure:Picture Naming Test(PNT) |
39.19; 38.31; 46.75; 43.31; 52.25; 48.31 | — |
| SECONDARY Follow-up Measurement: Hamilton Depression Rating Scale (HAMD) |
5.63; 5.25; 4.94; 4.63; 4.06; 3.88 | — |
| SECONDARY Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA) |
4.88; 4.63; 4.13; 4.00; 3.56; 3.25 | — |
| SECONDARY Follow-up Measurement: Mini-Mental State Examination (MMSE) |
23.81; 23.88; 25.38; 25.00; 26.38; 26.19 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03588572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.