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Language Functional Reorganization in Subcortical Infarction Patients

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ClinicalTrials.gov Identifier: NCT03668132
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Yan Liu, Guangzhou General Hospital of Guangzhou Military Command

Brief Summary:

Post stroke aphasia (PSA) is one of the most frequently happened deficiency of stoke, affecting speaking,comprehension, writing and reading of language. Generally, PSA is commonly seen in cortical damage, but in recent years it has been found that subcortical injury is also an important cause of PSA, which is called subcortical aphasia. Using fMRI technology, the investigators aim to investigate the language function of patients with subcortical cerebral infarction at different stages of recovery , and explored the mechanism of post-injury language reorganization in the brain.

The investigators recruited 60 first-episode acute cerebral infarction patients with one-side lesion in subcortical white matter (40 with left injury and 20with right injury) and 20 health volunteers. All participants are right-handed, and screened with MMSE, HAMD and HAMA to exclude cases of psychosis, post-stroke dementia and depression. Each participant was arranged to have three test sessions at different stages after the infarction (T1:within 3 days after onset of the stroke ; T2:28 ±3days after onset; T3: 90±3days after onset), with fMRI and Western aphasia battery (WAB) in each session.

The purpose of this study is to explore the pathogenesis of subcortical aphasia, and to understand the dynamic reorganization of language network during the recovery of language function.


Condition or disease Intervention/treatment
Subcortical Aphasia Ischemic Stroke Other: ischemic brain damage

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Language Functional Reorganization Following Subcortical Cerebral Infarction: A Longitudinal fMRI Study
Actual Study Start Date : January 19, 2016
Actual Primary Completion Date : October 9, 2016
Actual Study Completion Date : January 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Group/Cohort Intervention/treatment
Left damage
Have the ischemic brain damage and the location of the damage ,and in the left brain
Other: ischemic brain damage
Have or not have the ischemic brain damage and the location of the damage

Right damage
Have the ischemic brain damage and the location of the damage ,and in the right brain
Other: ischemic brain damage
Have or not have the ischemic brain damage and the location of the damage

Normal control
Not have the ischemic brain damage
Other: ischemic brain damage
Have or not have the ischemic brain damage and the location of the damage




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 within 3 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 within 3 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 within 3 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. Follow-up measurement:Functional Magnetic Resonance Imaging(fMRI) [ 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 within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization. ]
    The examine included task-state fMRI and resting-state 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..



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The first onset, the onset time was less than 3 days, the lesion was the left and right single subcortical infarct lesion confirmed by head Magnetic Resonance Imaging(MRI).All of them are come from Neurology/Cerebrovascular Department General Hospital of Guangzhou Military Command of PLA between 2016-2017.
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.
  • Pregnant women and breast-feeding women.
  • Contraindication of MRI scanning.

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): NCT03668132


Locations
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China, Guangdong
Cerebrovascular Department of General Hospital of Guangzhou Military Command of PLA
GuangZhou, Guangdong, China, 510010
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

Publications:

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Responsible Party: Yan Liu, Director of cerebrovascular department, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT03668132     History of Changes
Other Study ID Numbers: LY-89514138
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Aphasia
Functional magnetic resonance imaging
Subcortical aphasia
Post-stroke aphasia
Cortical activation

Additional relevant MeSH terms:
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Infarction
Aphasia
Ischemia
Pathologic Processes
Necrosis
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms