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

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ClinicalTrials.gov Identifier: NCT03588572
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Yan Liu, Guangzhou General Hospital of Guangzhou Military Command

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.


Condition or disease Intervention/treatment Phase
Subcortical Aphasia Ischemic Stroke Drug: Venlafaxine hydrochloride capsules Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: The investigator learned about the experimental grouping and medication situation, but the subjects did not know until the end of the experiment.
Primary Purpose: Treatment
Official Title: A Randomized, Single Blind, Controlled, Longitudinal Study of the Effects of Venlafaxine Hydrochloride Capsules on the Language Function of Stroke Patients With Subcortical Aphasia Using fMRI
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: Venlafaxine Group
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
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
Other Name: EFFEXOR XR

No Intervention: Controlled group
the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.



Primary Outcome Measures :
  1. A change of outcome measure:the Chinese version of Western Aphasia Battery(WAB) [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. A change of outcome measure:Spontaneous Language Frequency Test(SLFT) [ Time Frame: 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. ]
    This test mainly assesses spontaneous speech fluency of participants.It requires participants name as many food names as possible within one minute, and each correct one to give one point.The higher the score, the better the language function.

  2. A change of outcome measure:Picture Naming Test(PNT) [ Time Frame: 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. ]
    This test mainly assesses the ability of picture name of participants.we used a program for displaying named pictures on a computer screen (60 photos in total, of which 20 were Chinese celebrity faces). Each image was displayed in 3 seconds, and 1 point was correctly named for an image.The faces of celebrities were selected from the picture database of Chinese celebrities in the State Key Laboratory of Cognitive Neuroscience and Learning at Beijing Normal University.Score fluctuation is 0-60 points, the higher the score, the better the ability of picture name.

  3. A change of outcome measure: Functional Magnetic Resonance Imaging(fMRI) [ Time Frame: We will explore the mechanisms of dynamic changes in language functions. Thus, participates will undergo this examine on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization. ]
    The examine included task-state fMRI and resting-state fMRI

  4. Follow-up measurement: Hamilton Depression Rating Scale (HAMD) [ Time Frame: 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. ]
    The Hamilton Depression Rating Scale (HAMD) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored from 0-2. HAMD Scoring Instructions:0-7=Normal, 8-13 = Mild Depression, 14-18 = Moderate Depression, 19-22 = Severe Depression, ≥ 23 = Very Severe Depression(i.e.,the higher the score, the greater the likelihood of depression).

  5. Follow-up measurement: Hamilton Anxiety Rating Scale (HAMA) [ Time Frame: 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. ]
    The Hamilton Anxiety Rating Scale (HAMA) is a widely used and well-validated tool for measuring the severity of a patient's anxiety. The HAMA is composed of 14 items and takes 15-20 minutes to complete the interview and score the results. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe.HAMA Scoring Instructions:0-8=Normal, 8-13= Possible Anxiety, 14-17 = Mild Anxiety, 18-24 = Moderate Anxiety, 25-30 = Severe Anxiety(i.e.,the higher the score, the greater the likelihood of anxiety).

  6. Follow-up measurement: Mini-Mental State Examination (MMSE) [ Time Frame: 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. ]
    The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Administration of the test takes between 5 and 10 minutes. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.The raw score may also need to be corrected for educational attainment and age.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588572


Contacts
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Contact: Liu Yan, PhD 0086-02088654756 yanliu@139.com
Contact: Wang Lingjie, Master 0086-15626046566 1091705489@qq.com

Locations
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China, Guangdong
Guangzhou General Hospital of Guangzhou Military Command Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Zhao Wei    008618818857587    853777216@qq.com   
Cerebrovascular Department of General Hospital of Guangzhou Military Command of PLA Not yet recruiting
GuangZhou, Guangdong, China, 510010
Contact: Liu Yan, PhD    0086-02088654756    yanliu@139.com   
Contact: Wang Lingjie, Master    0086-15626046566    1091705489@qq.com   
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
Investigators
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Study Chair: Liu Yan, PhD Guangzhou General Hospital of Guangzhou Military Command
  Study Documents (Full-Text)

Documents provided by Yan Liu, Guangzhou General Hospital of Guangzhou Military Command:
Statistical Analysis Plan  [PDF] August 1, 2018
Study Protocol  [PDF] August 21, 2018


Publications of Results:

Other Publications:
Kertesz A. Western Aphasia Battery test manual. New York:NY: Grune & Stratton,1982.

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Responsible Party: Yan Liu, Department director, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT03588572     History of Changes
Other Study ID Numbers: LY-81471172
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yan Liu, Guangzhou General Hospital of Guangzhou Military Command:
Behavioural evaluation
Functional magnetic resonance imaging
Venlafaxine

Additional relevant MeSH terms:
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Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs