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.
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interventional
120
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2025
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2025
CompletedStudy Start
First participant enrolled
December 31, 2025
CompletedFirst Posted
Study publicly available on registry
January 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
January 21, 2026
December 1, 2025
1.7 years
September 28, 2025
January 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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
Baseline and Week 4 post-intervention
Secondary Outcomes (4)
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
Study Arms (3)
Experimental Group for Traditional Chinese Medicine Pentatonic Sound Therapy
EXPERIMENTALTherapeutic 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.
Melodic Intonation Therapy Treatment Group
ACTIVE COMPARATORMelodic 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.
Conventional control group
ACTIVE COMPARATOR① 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 28, 2025
First Posted
January 9, 2026
Study Start
December 31, 2025
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2028
Last Updated
January 21, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
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.