Language Functional Reorganization in Subcortical Infarction Patients

NCT03668132 | Completed

• 1 other identifier: LY-89514138
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Subcortical Aphasia; Ischemic Stroke

Keywords

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

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 within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.

Secondary Outcomes (3)

• 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 within 3 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 within 3 days (V1), 28±3 days (V2), and 90±3 days(V3) after randomization.

• Follow-up measurement:Functional Magnetic Resonance Imaging(fMRI)

  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.

Study Arms (3)

Left damage

Have the ischemic brain damage and the location of the damage ,and in the left brain

Other: ischemic brain damage

Right damage

Have the ischemic brain damage and the location of the damage ,and in the right brain

Other: ischemic brain damage

Normal control

Not have the ischemic brain damage

Other: ischemic brain damage

Interventions

ischemic brain damage OTHER

Have or not have the ischemic brain damage and the location of the damage

Left damage; Normal control; Right damage

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.
• Pregnant women and breast-feeding women.
• Contraindication of MRI scanning.

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

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; Aphasia

Condition Hierarchy (Ancestors)

Stroke; 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; Pathological Conditions, Signs and Symptoms

Study Officials

• Liu Yan, PhD

  Guangzhou General Hospital of Guangzhou Military Command

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of cerebrovascular department

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: January 19, 2016
• Primary Completion: October 9, 2016
• Study Completion: January 12, 2017
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

CN (1)