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.

NCT ID: NCT07329751

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-09-30

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.

Conditions

Aphasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Traditional Chinese Medicine Five-Tone Therapy

Intervention Type: OTHER

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:

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.

Group Type: ACTIVE_COMPARATOR

Melodic Intonation Training

Intervention Type: OTHER

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:

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.

Group Type: ACTIVE_COMPARATOR

Standard speech therapy; Routine medical treatment; Health education

Intervention Type: OTHER

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.

Interventions

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:

Intervention Type: OTHER

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:

Intervention Type: OTHER

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 (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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fujian University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ruiming Nan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jia Huang, Doctor

Role: CONTACT

jasmine1874@163.com

+8659188529125

Other Identifiers

Jia Huang

Identifier Type: -

Identifier Source: org_study_id