AphasiaNCT07329751
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.
A study testing Traditional Chinese Medicine Five-Tone Therapy, Melodic Intonation Training and Standard speech therapy; Routine medical treatment; Health education in people with Aphasia, run by Fujian University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aphasia
- What is being tested?
- Traditional Chinese Medicine Five-Tone Therapy, Melodic Intonation Training and Standard speech therapy; Routine medical treatment; Health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Traditional Chinese Medicine Five-Tone Therapy, Melodic Intonation Training, Standard speech therapy; Routine medical treatment; Health education
- Keywords
- aphasia, stroke, pentatonic scales of chinese medicine
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine Five-Tone TherapyOther
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 TrainingOther
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:
Standard speech therapy; Routine medical treatment; Health educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Standard speech therapy; Routine medical treatment; Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline and Week 4 post-intervention
Secondary outcomes (4)
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
Measured: Baseline and Week 4 post-intervention
Minimum Mental State Examination
MMSE total score: 30 points
- Cognitive impairment: Maximum score 30 points; scores 27-30 indicate normal cognition, while scores <27 indicate cognitive impairment.
- Dementia classification criteria: Illiterate ≤ 17 points Primary education ≤ 20 points Secondary education (including technical secondary) ≤ 22 points Tertiary education (including college) ≤ 23 points
- 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.
Measured: 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.
Measured: 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.'
Measured: Baseline and Week 4 post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start31 Dec 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruiming Nan, Fujian University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329751
- Sponsor's protocol ID
- Jia Huang
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07329751
- Acronym / sponsor ID
- Jia Huang
- Conditions
- Aphasia
- Keywords
- aphasia, stroke, pentatonic scales of chinese medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fujian University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group for Traditional Chinese Medicine Pentatonic Sound Therapy | Experimental | Other: Traditional Chinese Medicine Five-Tone TherapyTherapeutic 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 comparator | Other: Melodic Intonation TrainingMelodic 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 comparator | Other: Standard speech therapy; Routine medical treatment; Health education① 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese Medicine Five-Tone TherapyTherapeutic 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: | Other | Experimental Group for Traditional Chinese Medicine Pentatonic Sound Therapy |
| Melodic Intonation TrainingAll 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: | Other | Melodic Intonation Therapy Treatment Group |
| Standard speech therapy; Routine medical treatment; Health education① 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 | Conventional control group |
Primary outcome
Semantic Fluency Test
Time frame: 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
Time frame: 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
4 secondary outcomes
Boston Diagnostic Aphasia Examination，BDAE
Time frame: Baseline and Week 4 post-intervention
Minimum Mental State Examination
Time frame: Baseline and Week 4 post-intervention
Western Aphasia Battery，WAB
Time frame: Baseline and Week 4 post-intervention
Chinese Functional Communication Profile, CFCP
Time frame: Baseline and Week 4 post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese Medicine Five-Tone Therapy, Melodic Intonation Training and Standard speech therapy; Routine medical treatment; Health education in people with Aphasia, run by Fujian University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Huang, Doctor (+8659188529125, jasmine1874@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semantic Fluency Test (time frame: Baseline and Week 4 post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.