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.

Fujian University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Aphasia

Treatments: Other: Traditional Chinese Medicine Five-Tone Therapy; Other: Melodic Intonation Training; Other: Standard speech therapy; Routine medical treatment; Health education

Study type: Interventional

Funder types: Other

Identifiers

NCT07329751

Jia Huang

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 3 patient groups

Experimental Group for Traditional Chinese Medicine Pentatonic Sound Therapy

Experimental group

Description:

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.

Treatment:

Other: Traditional Chinese Medicine Five-Tone Therapy

Melodic Intonation Therapy Treatment Group

Active Comparator group

Description:

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.

Treatment:

Other: Melodic Intonation Training

Conventional control group

Active Comparator group

Description:

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.

Treatment:

Other: Standard speech therapy; Routine medical treatment; Health education