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Post-stroke AphasiaNCT07684781

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

A study testing Electroacupuncture and Basic treatment + Speech therapy in people with Post-stroke Aphasia and PSA, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Post-stroke Aphasia, PSA
What is being tested?
Electroacupuncture and Basic treatment + Speech therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteVietnam
Study dates
Jul 2026to Jan 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Linh T Nguyen, MD, MSc contact

+84-909979717

thailinh@ump.edu.vn

Vietnam1 site
  • Faculty of Traditional medicine - University of Medicine and Pharmacy at Ho Chi Minh City

    Ho Chi Minh City, 700000

    Head of Department, (+84-28) 3844 2756, khoayhct@ump.edu.vn

Other trials in Vietnam

About this study

Official title: 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:

Read more
  • 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.
Read the detailed description

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.

Being tested
Electroacupuncture, Basic treatment + Speech therapy, Sham Electroacupuncture
Keywords
Post-stroke aphasia, Electroacupuncture, Speech therapy, Language recovery, Clinical trial
Medical subject headings
Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElectroacupunctureOther

    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.

  • Basic treatment + Speech therapyOther

    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).

  • Sham ElectroacupunctureOther

    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.

Study groups in NCT07684781
Study groupRoleWhat they receive
Electroacupuncture (Xuanzhong, Tongli) + Basic Treatment with Speech therapyExperimentalParticipants 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).
Receives: Other: Electroacupuncture; Other: Basic treatment + Speech therapy
Sham Electroacupuncture + Basic Treatment with Speech therapySham comparatorParticipants 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).
Receives: Other: Basic treatment + Speech therapy; Other: Sham Electroacupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)
  1. The change in ART scores

    This is a quantitative variable measured in scores, used to evaluate language recovery in patients with post-stroke aphasia.

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

  2. The change in SAQOL-39 scores

    A quantitative variable assessing quality of life for patients with stroke and aphasia.

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

  3. Adverse effects

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

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
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07684781
Sponsor's protocol ID
358/ĐHYD-HĐĐĐ
Status last verified
Jun 2026
First submitted
29 Jun 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 34161953

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupuncture and Basic treatment + Speech therapy in people with Post-stroke Aphasia and PSA, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

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 7 inclusion and 6 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Linh T Nguyen, MD, MSc (+84-909979717, thailinh@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in BDAE scores (time frame: From Baseline (T0) to Week 2 (T1), and Week 4 (T2).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07684781, which also lists 4 linked publications.

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 6 Jul 2026.

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