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

NCT03588572 | Completed Results

• 1 other identifier: LY-81471172
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Subcortical Aphasia; Ischemic Stroke

Keywords

Behavioural evaluation; Functional magnetic resonance imaging; Venlafaxine

Outcome Measures

Primary Outcomes (1)

• A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB)

  The main outcome measure for this scale is Aphasia Quotient(AQ) which mainly tests the ability of spontaneous speech, oral comprehension, repetition, and naming, and reflects the severity of aphasia, and can be used as a reliable indicator to evaluate the improvement and deterioration of aphasia. Score fluctuation is 0-100 points, the normal value is 98.4-100 points, AQ\<93.8 can be judged as language dysfunction.

  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.

Secondary Outcomes (5)

• A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT)

  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.

• A Change of Outcome Measure:Picture Naming Test(PNT)

  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.

• Follow-up Measurement: Hamilton Depression Rating Scale (HAMD)

  We must determine that the participant is not in depression at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.

• Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA)

  We must determine that the participant is not in anxiety at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.

• Follow-up Measurement: Mini-Mental State Examination (MMSE)

  We must determine that the participant is not in moderate or more cognitive impairment at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.

Study Arms (2)

Venlafaxine Group

EXPERIMENTAL

The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.

Drug: Venlafaxine hydrochloride capsules

Controlled group

NO INTERVENTION

the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.

Interventions

Venlafaxine hydrochloride capsules DRUG

The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization

Also known as: EFFEXOR XR®

Venlafaxine Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (2)

Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, 510000, China

Location

Cerebrovascular Department of General Hospital of Guangzhou Military Command of PLA

Guangzhou, Guangdong, 510010, China

Location

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MeSH Terms

Conditions

Ischemic Stroke

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Results Point of Contact

• Title: Dr.Yan Liu
• Organization: Guangzhou General Hospital of Guangzhou Military Command

yanliu@139.com

0086-02088654756

Study Officials

• Liu Yan, PhD

  Guangzhou General Hospital of Guangzhou Military Command

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The investigator learned about the experimental grouping and medication situation, but the subjects did not know until the end of the experiment.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department director

Model Details: On the basis of conventional clinical treatment in both groups, the experimental group was given drug intervention, and the control group was not given drug treatment.

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 17, 2018
• Study Start: August 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 13, 2021
• Results First Posted: October 3, 2019

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)