An interventional study of Traditional Chinese Medicine Five-Tone Therapy and Melodic Intonation Training in Aphasia, sponsored by Fujian University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Fujian University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
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)
Exclusion Criteria:
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)
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.
Other: Traditional Chinese Medicine Five-Tone Therapy
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.
Other: Melodic Intonation Training
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.
Other: Standard speech therapy; Routine medical treatment; Health education
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:
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:
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.
Semantic Fluency Test
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.
Time frame: Baseline and Week 4 post-intervention
Speech fluency test
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
Time frame: Baseline and Week 4 post-intervention
Boston Diagnostic Aphasia Examination，BDAE
BDAE Aphasia Severity Grading Scale ranges from 0 to 5, with higher grades indicating better language ability. Grading and Language Performance Grade 0: No meaningful speech; no auditory comprehension. Grade 1: Discontinuous speech in communication, but mostly requiring listeners to infer, ask questions, and guess; limited scope of communicable information; listeners find verbal communication difficult. Level 2: With listener assistance, conversation on familiar topics may be possible. However, expressing thoughts on unfamiliar subjects is often impossible, causing difficulty for both patient and examiner. Level 3: With minimal or no assistance, the patient can discuss nearly all everyday matters. Yet, due to diminished verbal and/or comprehension abilities, certain conversations prove difficult or unlikely. Level 4: Speech is fluent, though perceptible comprehension difficulties may be noted. Thought and verbal expression remain largely unrestricted. Level 5: Minimal discernible spee
Time frame: Baseline and Week 4 post-intervention
Minimum Mental State Examination
MMSE total score: 30 points 1. Cognitive impairment: Maximum score 30 points; scores 27-30 indicate normal cognition, while scores \<27 indicate cognitive impairment. 2. Dementia classification criteria: Illiterate ≤ 17 points Primary education ≤ 20 points Secondary education (including technical secondary) ≤ 22 points Tertiary education (including college) ≤ 23 points 3. Dementia severity grading: Mild: MMSE ≥ 21 points Moderate: MMSE 10-20 points Severe: MMSE ≤ 9 points The Mini-Mental State Examination assesses cognitive function. The scale ranges from 0 to 30 points, with higher scores indicating better cognitive function.
Time frame: Baseline and Week 4 post-intervention
Western Aphasia Battery，WAB
The Western Aphasia Battery Aphasia Quotient (AQ) is calculated from four component scores: spontaneous speech, auditory comprehension, repetition, and naming, with a maximum total of 100 points. An AQ score below 93.8 indicates diagnostic aphasia. The assessment comprises four major components: spontaneous speech (20 points total, divided into information content 10 points and flow 10 points), listening comprehension (10 points), repetition (10 points), and naming (10 points). The Aphasia Quotient (AQ) is then calculated. A higher Aphasia Quotient indicates better language ability.
Time frame: Baseline and Week 4 post-intervention
Chinese Functional Communication Profile, CFCP
Scale Name: Functional Language Communication Ability Assessment Scale Score Range: 0 to 100 points Score Interpretation: Higher scores indicate better functional communication abiity. 'The Functional Language Communication Ability Assessment Scale evaluates patients' practical communication skills in everyday life situations. The scale's total score ranges from 0 to 100 points, with higher scores representing superior functional communication ability.'
Time frame: Baseline and Week 4 post-intervention
No study locations are listed for this record.
Plan to share: No — Data sharing will be subject to strict limitations to comply with the General Data Protection Regulation (GDPR), HIPAA (where applicable in the United States), and other relevant data privacy regulations. Neither our agreement with the Ethics Committee nor the participants' informed consent forms envisage data being shared broadly for purposes beyond the specific analysis plan of this trial.
No publications or documents are linked to this record.
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Fujian University of Traditional Chinese Medicine