Effectiveness of Electroacupuncture at Xuanzhong (GB39) and Tongli (HT5) Points in Post-Stroke Aphasia

Официальное название

Evaluation of the Effectiveness of Electroacupuncture at Xuanzhong (GB39) and Tongli (HT5) Acupoints in Patients With Post-Stroke Aphasia

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Electroacupuncture
  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.
• Другое Basic treatment + Speech therapy
  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).
• Другое Sham Electroacupuncture
  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.

Первичные конечные точки

• The change in BDAE scores [Срок оценки: From Baseline (T0) to Week 2 (T1), and Week 4 (T2).]

Вторичные конечные точки (3)

• The change in ART scores [Срок оценки: From Baseline (T0) to Week 2 (T1) and Week 4 (T2).]
• The change in SAQOL-39 scores [Срок оценки: From Baseline (T0) to Week 4 (T2), and Week 12 (3-month Post-treatment Follow-up) (T3)]
• Adverse effects [Срок оценки: From Baseline (T0) to Week 2 (T1) and Week 4 (T2).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• Faculty of Traditional medicine - University of Medicine and Pharmacy at Ho Chi Minh City — Ho Chi Minh City

Публикации

• 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. PMID 36530615
• 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. PMID 29230621
• 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. PMID 28868952
• 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. PMID 34161953

Идентификаторы

NCT: NCT07684781 · 358/ĐHYD-HĐĐĐ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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