The Effect of Venlafaxine on Language Function in Patients With Subcortical Aphasia: A fMRI Study

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou General Hospital of Guangzhou Military Command
• Treatments: Venlafaxine Hydrochloride

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.