Effectiveness of Electroacupuncture at Xuanzhong (GB39) and Tongli (HT5) Points in Post-Stroke Aphasia
Evaluation of the Effectiveness of Electroacupuncture at Xuanzhong (GB39) and Tongli (HT5) Acupoints in Patients With Post-Stroke Aphasia
Post-stroke aphasia (PSA) is a prevalent and debilitating condition that significantly impairs communication, social participation, and quality of life, often leading to increased long-term healthcare costs and psychological burden. While speech therapy is the recommended standard of care, many patients face limitations in recovery, prompting exploration into integrative approaches. Traditional medicine, particularly electroacupuncture, has shown potential in enhancing neuro-functional recovery; however, further evidence is needed to optimize its integration with standard rehabilitative protocols. This study evaluates the clinical efficacy of electroacupuncture at the Xuanzhong (GB39) and Tongli (HT5) acupoints combined with standardized speech therapy, aiming to improve language outcomes and patient quality of life.
The goal of this clinical trial is to evaluate the clinical efficacy of electroacupuncture at the Xuanzhong (GB39) and Tongli (HT5) acupoints combined with speech therapy in patients with post-stroke aphasia, aged 18 to 75. The main questions it aims to answer are:
- Does electroacupuncture at the Xuanzhong and Tongli acupoints, combined with speech therapy and standard treatment, improve language recovery more effectively than the standard protocol alone, as measured by the BDAE and ART scales?
- Does this combined approach significantly improve the quality of life (SAQOL-39) and correlate with functional language recovery in post-stroke patients?
Researchers will compare the intervention group (electroacupuncture at Xuanzhong and Tongli combined with basic treatment and speech therapy) to a control group (electroacupuncture at other acupoints combined with basic treatment and speech therapy) to see if the specific acupoint combination enhances language rehabilitation.
Participants will:
- Undergo 4 weeks of electroacupuncture (once daily, 5 days per week) and speech therapy sessions.
- Complete assessments of language function (BDAE, ART) and quality of life (SAQOL-39) at baseline, 2 weeks, 1 month, and 3 months.
- Be monitored for any adverse effects, such as local pain, bleeding, bruising, or needle fainting, throughout the trial period.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Participants and Methods: A randomized, single-blind, controlled trial will be conducted at the Military Medical Hospital 175, HCMC Hospital Orthopedics and Rehabilitation, and HCMC Hospital for Rehabilitation - Professional Diseases, involving patients aged 18 to 75 years diagnosed with post-stroke aphasia (PSA). Participants must meet defined inclusion criteria and not fall under any exclusion criteria, such as severe comorbid heart, liver, or kidney failure.
Randomization and Grouping: Participants will be randomly assigned into two groups in a 1:1 ratio using block randomization with stratification by study site. The intervention group will receive electroacupuncture at the Xuanzhong (GB39) and Tongli (HT5) acupoints, combined with standardized speech therapy and basic medical treatment. The control group will receive electroacupuncture at non-acupoint locations, combined with the same standardized speech therapy and basic medical treatment.
Procedure and Assessments: Both groups will receive 4 weeks of intervention, with electroacupuncture sessions conducted once daily, 5 days per week. Speech therapy will be performed daily for 30 minutes, 5 days per week. Clinical outcomes including the BDAE scale and ART will be assessed at baseline (T0), after 2 weeks (T1), and 1 month after treatment (T2). Quality of life (SAQOL-39) will be assessed at baseline (T0), 1 month after treatment (T2), and at a 3-month follow-up (T3). Adverse effects, such as local pain, bleeding, bruising, dizziness, or needle fainting, will be carefully monitored and recorded throughout the study period.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Linh T Nguyen, MD, MSc
- Número de teléfono: +84-909979717
- Correo electrónico: thailinh@ump.edu.vn
Ubicaciones de estudio
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Ho Chi Minh City, Vietnam, 700000
- Faculty of Traditional medicine - University of Medicine and Pharmacy at Ho Chi Minh City
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Contacto:
- Head of Department
- Número de teléfono: (+84-28) 3844 2756
- Correo electrónico: khoayhct@ump.edu.vn
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age: 18 to 75 years.
- Diagnosis: Diagnosed with post-stroke aphasia (PSA) based on the Ministry of Health criteria or ICD-10 codes (I60-I64).
- Cognitive and Functional State: Alert and able to cooperate with the treatment.
- Language Assessment: Aphasia classified as moderate or mild according to the BDAE scale (scores 2-4).
- Disease Duration: Stroke occurring 7 to 90 days prior to enrollment.
- Language Proficiency: Native Vietnamese speaker.
- Informed Consent: Must voluntarily sign the informed consent form and agree to comply with all study requirements.
Exclusion Criteria:
- Non-Stroke Related Aphasia: Pre-existing aphasia or aphasia not caused by a stroke.
- Severe Comorbidities: Severe heart, liver, or kidney failure.
- Psychiatric/Cognitive Disorders: Diagnosed dementia or other mental health conditions.
- Medical Contraindications: Presence of a pacemaker.
- Dermatological Conditions: Infection at the targeted acupoint sites.
- Sensory Impairment: Significant hearing or visual impairment that interferes with assessment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Electroacupuncture (Xuanzhong, Tongli) + Basic Treatment with Speech therapy
Participants receive daily electroacupuncture at Xuanzhong (GB39) and Tongli (HT5) acupoints (2 Hz, 2mA, 20-minute retention) for 5 days per week over a 4-week period.
This is combined with the hospital's basic treatment protocol, which includes standard medical management (blood pressure, lipid, and glucose control; antiplatelet therapy) and 30 minutes of daily speech therapy (5 days per week).
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Electroacupuncture: Performed using a KWD-808I electroacupuncture device, set at a frequency of 2 Hz and an intensity of 2 mA. Acupoint Formula: Xuanzhong (3 cun above the apex of the lateral malleolus) and Tongli (1 cun above the transverse crease of the wrist, on the radial side of the flexor carpi ulnaris tendon). Procedure: Needles are inserted rapidly to achieve deqi, with a retention time of 20 minutes per session.
Participants receive standard basic treatment (management of blood pressure, lipids, blood glucose, and antiplatelet therapy) alongside speech therapy (30 minutes/session, 5 days/week for 4 weeks).
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Comparador falso: Sham Electroacupuncture + Basic Treatment with Speech therapy
Participants receive daily sham electroacupuncture at non-acupoint locations (1 cm from Xuanzhong and Tongli, 0 mA intensity) for 5 days per week over a 4-week period.
This is combined with the same basic treatment protocol as the intervention group, including standard medical management and 30 minutes of daily speech therapy (5 days per week).
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Participants receive standard basic treatment (management of blood pressure, lipids, blood glucose, and antiplatelet therapy) alongside speech therapy (30 minutes/session, 5 days/week for 4 weeks).
Performed using the same electroacupuncture device, but with the intensity set to 0 mA to maintain blinding. Insertion Sites: Non-acupoint 1 (1 cm lateral to the Xuanzhong point towards the fibula) and Non-acupoint 2 (1 cm medial to the Tongli point towards the ulna). Procedure: Needles are inserted rapidly without deqi manipulation, with a retention time of 20 minutes per session. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The change in BDAE scores
Periodo de tiempo: From Baseline (T0) to Week 2 (T1), and Week 4 (T2).
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This is a quantitative variable measured in scores.
The BDAE (Boston Diagnostic Aphasia Examination) scale evaluates language function through 8 components.
Higher improvement in the total score indicates better language rehabilitation.
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From Baseline (T0) to Week 2 (T1), and Week 4 (T2).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The change in ART scores
Periodo de tiempo: From Baseline (T0) to Week 2 (T1) and Week 4 (T2).
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This is a quantitative variable measured in scores, used to evaluate language recovery in patients with post-stroke aphasia.
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From Baseline (T0) to Week 2 (T1) and Week 4 (T2).
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The change in SAQOL-39 scores
Periodo de tiempo: From Baseline (T0) to Week 4 (T2), and Week 12 (3-month Post-treatment Follow-up) (T3)
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A quantitative variable assessing quality of life for patients with stroke and aphasia.
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From Baseline (T0) to Week 4 (T2), and Week 12 (3-month Post-treatment Follow-up) (T3)
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Adverse effects
Periodo de tiempo: From Baseline (T0) to Week 2 (T1) and Week 4 (T2).
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This is a categorical variable (Yes/No) recording clinical adverse events such as local pain, bleeding, bruising, dizziness, or needle fainting during the trial period.
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From Baseline (T0) to Week 2 (T1) and Week 4 (T2).
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Xu M, Gao Y, Zhang H, Zhang B, Lyu T, Tan Z, Li C, Li X, Huang X, Kong Q, Xiao J, Kranz GS, Li S, Chang J. Modulations of static and dynamic functional connectivity among brain networks by electroacupuncture in post-stroke aphasia. Front Neurol. 2022 Dec 1;13:956931. doi: 10.3389/fneur.2022.956931. eCollection 2022.
- Li LL, Liu XW, Wu F, Tong DC, Ye LP, Tao HX, Liu P, Qiu YH, Yang WZ. Electroacupuncture Stimulation of Language-Implicated Acupoint Tongli (HT 5) in Healthy Subjects: An fMRI Evaluation Study. Chin J Integr Med. 2018 Nov;24(11):822-829. doi: 10.1007/s11655-017-2924-8. Epub 2017 Dec 11.
- Liu S, Li M, Tang W, Wang G, Lv Y. An fMRI study of the effects on normal language areas when acupuncturing the Tongli (HT5) and Xuanzhong (GB39) acupoints. J Int Med Res. 2017 Dec;45(6):1961-1975. doi: 10.1177/0300060517720344. Epub 2017 Sep 4.
- Zhang Y, Wang Z, Jiang X, Lv Z, Wang L, Lu L. Effectiveness of Acupuncture for Poststroke Aphasia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Complement Med Res. 2021;28(6):545-556. doi: 10.1159/000512672. Epub 2021 Jun 23.
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Finalización del estudio (Estimado)
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Manifestaciones neuroconductuales
- Trastornos del neurodesarrollo
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Desordenes comunicacionales
- Terapéutica
- Terapias complementarias
- Modalidades de fisioterapia
- Atención al paciente
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Anestesia y analgesia
- Rehabilitación de trastornos del habla y del lenguaje
- Terapia de estimulación eléctrica
- Terapia de modalidad combinada
- Anestesia
- Analgesia
- Terapia de acupuntura
- Estimulación del nervio eléctrico transcutáneo
- Terapia del habla
- Electroacupuntura
Otros números de identificación del estudio
- 358/ĐHYD-HĐĐĐ
Plan de datos de participantes individuales (IPD)
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Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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