Based on the Spatio-temporal Coding Characteristics of Frontotemporal Network, This Paper Explores the Mechanism of Five-tone Speech Training in Reshaping Language Fluency Function.

Обзор

To explore the mechanism of five-tone speech training in reshaping language fluency function and the clinical efficacy of aphasia language function, daily communication ability and communication efficiency based on the temporal and spatial coding characteristics of frontotemporal network. Combined with EEG ( rsEEG, ERP ), nuclear magnetic resonance examination and near-infrared imaging system examination to explore its effect on brain electrophysiological activity. So as to promote the modernization of traditional Chinese medicine rehabilitation treatment technology and the popularization and application of speech rehabilitation treatment technology.

Вмешательства

• Другое Traditional Chinese Medicine Five-Tone Therapy
  Therapeutic Protocol for 'Five-Tone' Therapy Based on Melodic Intonation Training Model: Subjects undergo syndrome differentiation and treatment, with corresponding 'Five-Tone' melodies selected. Based on the melodic intonation training model, active training is conducted through melodic intervention measures. ① Rehabilitation training② Conventional Medical Management.③ Health Education:
• Другое Melodic Intonation Training
  All eligible participants enrolled in the study received four weeks of melodic intonation therapy, administered once daily for 40 minutes, five days per week.① Rehabilitation training② Conventional Medical Management.③ Health Education:
• Другое Standard speech therapy; Routine medical treatment; Health education
  ① Rehabilitation training: Physicians conduct limb movement and speech rehabilitation training for participants in accordance with the Clinical Evidence-Based Practice Guidelines for Integrated Traditional and Western Medicine Rehabilitation of Stroke (2024 Edition). ② Conventional Medical Management: Standard foundational treatment is administered to enrolled subjects in accordance with the National Health Commission's Guidelines for the Prevention and Treatment of Cerebrovascular Diseases (202

Первичные конечные точки

• Semantic Fluency Test [Срок оценки: Baseline and Week 4 post-intervention]
• Speech fluency test [Срок оценки: Baseline and Week 4 post-intervention]

Вторичные конечные точки (4)

• Boston Diagnostic Aphasia Examination，BDAE [Срок оценки: Baseline and Week 4 post-intervention]
• Minimum Mental State Examination [Срок оценки: Baseline and Week 4 post-intervention]
• Western Aphasia Battery，WAB [Срок оценки: Baseline and Week 4 post-intervention]
• Chinese Functional Communication Profile, CFCP [Срок оценки: Baseline and Week 4 post-intervention]

Критерии участия

Eligibility Criteria

Критерии включения

Age between 18 and 70 years

Right-handed

Native Chinese speakers

Clinical diagnosis of post-stroke aphasia caused by ischemic stroke, confirmed by CT or MRI

Diagnosis of non-fluent aphasia based on the Western Aphasia Battery (WAB), with BDAE severity rating of 1-5

Time since stroke onset ≥ 2 weeks

Stable vital signs, clear consciousness, and no severe cognitive impairment

Ability to understand the study procedures and provide written informed consent (or consent provided by a legally authorized representative)

Критерии исключения

History of aphasia or neurological disease not caused by stroke (e.g., traumatic brain injury, brain tumor, neurodegenerative diseases)

Severe visual or auditory impairments that would interfere with task performance

Severe cognitive impairment or disorders of consciousness preventing cooperation with language assessment or intervention

Severe dysarthria or apraxia of speech that precludes valid language assessment

History of epilepsy or other severe neurological conditions

Severe systemic diseases (e.g., severe cardiopulmonary dysfunction, renal failure, hepatic failure, malignancy)

Psychiatric disorders (e.g., schizophrenia, severe depression, or other major psychiatric illnesses)

Contraindications to MRI or fNIRS assessment (e.g., metallic implants, severe claustrophobia)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07329751 · Jia Huang

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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