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

NCT07684781 | Not Yet Recruiting DMC

• 1 other identifier: 358/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-stroke Aphasia; PSA

Keywords

Post-stroke aphasia; Electroacupuncture; Speech therapy; Language recovery; Clinical trial

Outcome Measures

Primary Outcomes (1)

• The change in BDAE scores

  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.

  From Baseline (T0) to Week 2 (T1), and Week 4 (T2).

Secondary Outcomes (3)

• The change in ART scores

  From Baseline (T0) to Week 2 (T1) and Week 4 (T2).

• The change in SAQOL-39 scores

  From Baseline (T0) to Week 4 (T2), and Week 12 (3-month Post-treatment Follow-up) (T3)

• Adverse effects

  From Baseline (T0) to Week 2 (T1) and Week 4 (T2).

Study Arms (2)

Electroacupuncture (Xuanzhong, Tongli) + Basic Treatment with Speech therapy

EXPERIMENTAL

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).

Other: Electroacupuncture; Other: Basic treatment + Speech therapy

Sham Electroacupuncture + Basic Treatment with Speech therapy

SHAM COMPARATOR

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).

Other: Basic treatment + Speech therapy; Other: Sham Electroacupuncture

Interventions

Electroacupuncture OTHER

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.

Electroacupuncture (Xuanzhong, Tongli) + Basic Treatment with Speech therapy

Basic treatment + Speech therapy OTHER

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).

Electroacupuncture (Xuanzhong, Tongli) + Basic Treatment with Speech therapy; Sham Electroacupuncture + Basic Treatment with Speech therapy

Sham Electroacupuncture OTHER

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.

Sham Electroacupuncture + Basic Treatment with Speech therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

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

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Communication Disorders

Interventions

Electroacupuncture; Speech Therapy

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Rehabilitation of Speech and Language Disorders; Aftercare; Continuity of Patient Care; Patient Care

Central Study Contacts

Linh T Nguyen, MD, MSc

CONTACT

+84-909979717; thailinh@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be blinded to treatment group assignment. Study participants will remain unaware of their specific group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

VN (1)