NCT07329751

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

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Dec 2025

Typical duration for not_applicable

Status
not yet recruiting

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

Study Progress21%
Dec 2025Sep 2028

First Submitted

Initial submission to the registry

September 28, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

December 31, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

January 21, 2026

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

September 28, 2025

Last Update Submit

January 19, 2026

Conditions

Keywords

aphasiastrokepentatonic scales of chinese medicine

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

EXPERIMENTAL

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 Therapy Treatment Group

ACTIVE COMPARATOR

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

Conventional control group

ACTIVE COMPARATOR

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

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:

Experimental Group for Traditional Chinese Medicine Pentatonic Sound Therapy

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:

Melodic Intonation Therapy Treatment 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.

Conventional control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

AphasiaStroke

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Jia Huang, Doctor

CONTACT

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.