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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Semantic Fluency Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility Criteria
- •Inclusion Criteria:
- •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)
排除标准
- •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)
研究组 & 干预措施
Experimental Group for Traditional Chinese Medicine Pentatonic Sound 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 for active training based on the melodic intonation intervention model. Intervention duration: All eligible participants in this study received four weeks of treatment, administered once daily for 40 minutes, five days per week.
干预措施: Traditional Chinese Medicine Five-Tone Therapy (Other)
Melodic Intonation Therapy Treatment Group
Melodic intonation training. Intervention duration: All eligible participants enrolled in this study received treatment for 4 weeks, once daily for 40 minutes, with sessions conducted 5 days per week.
干预措施: Melodic Intonation Training (Other)
Conventional control group
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 (2024 Edition). This encompasses: management of underlying causes, blood pressure control, antiplatelet therapy, anticoagulant therapy, and regulation of blood glucose and lipid levels. ③ Health Education: Health education is provided to subjects to raise awareness of the severe risks associated with stroke and the available rehabilitation interventions.
干预措施: Standard speech therapy; Routine medical treatment; Health education (Other)
结局指标
主要结局
Semantic Fluency Test
时间窗: Baseline and Week 4 post-intervention
The semantic fluency test requires subjects to say as many words related to a given semantic category as possible within 60 seconds, such as furniture, occupation, etc. The more words they say, the better the surface semantic fluency.
Speech fluency test
时间窗: Baseline and Week 4 post-intervention
Verbal Fluency Test: Participants are required to produce as many words as possible within 60 seconds that belong to a specified phonetic category, such as words beginning with "yi". A higher number of words indicates greater apparent verbal fluency
次要结局
- Boston Diagnostic Aphasia Examination，BDAE(Baseline and Week 4 post-intervention)
- Minimum Mental State Examination(Baseline and Week 4 post-intervention)
- Western Aphasia Battery，WAB(Baseline and Week 4 post-intervention)
- Chinese Functional Communication Profile, CFCP(Baseline and Week 4 post-intervention)
研究者
Ruiming Nan
Professor
Fujian University of Traditional Chinese Medicine