Ischemic StrokeNCT07846488
Combined Acupuncture-Based Therapy for Rehabilitation After Ischemic Stroke
A study testing Electro-Field Acupuncture, Electro-Acupuncture and Cerebrolysin in people with Ischemic Stroke and Hemiplegia, run by National Hospital of Acupuncture, Vietnam at 1 site in Vietnam.
Trial summary
Objective: To assess the therapeutic efficacy of combined electroacupuncture (or electric field acupuncture), hydroacupuncture (Cerebrolysin or B-complex vitamins), and acupressure massage in restoring motor function and treating dysphagia in post-acute ischemic stroke patients, while evaluating safety profiles and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Hemiplegia, Neurogenic Dysphagia
- What is being tested?
- Electro-Field Acupuncture, Electro-Acupuncture and Cerebrolysin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2026to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Cerebral venous infarction, hemorrhagic transformation of cerebral infarction.
- Stage 3-4 heart failure, cerebral vascular malformations, cerebral air embolism, chronic obstructive pulmonary disease (COPD).
- Respiratory failure requiring endotracheal intubation, impaired consciousness.
- Concurrent systemic or neuropsychiatric conditions: tuberculosis, psychiatric disorders, HIV/AIDS, epilepsy, esophageal stricture, pyloric stenosis.
- Patients who have not received Cerebrolysin treatment during the acute phase.
- Non-cooperative patients, participants who fail to complete the full course of treatment, or patients whose clinical symptoms progressively worsen to a life-threatening level during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
National Hospital of Acupuncture
Hanoi, Hanoi, 10000
Ngoc Linh Thi Nguyen, MD, MSc, +84358961018, nguyenthingoclinh.bs249@gmail.com
Thanh Hoa Thi Phi, MD, PhD, +84968217057, Drthanhhoa@hotmail.com
About this study
Official title: A Randomized Controlled Trial Evaluating Electroacupuncture, Acupoint Injection, and Acupressure Massage for Motor and Swallowing Rehabilitation in Patients With Post-Acute Ischemic Stroke
Objective: To assess the therapeutic efficacy of combined electroacupuncture (or electric field acupuncture), hydroacupuncture (Cerebrolysin or B-complex vitamins), and acupressure massage in restoring motor function and treating dysphagia in post-acute ischemic stroke patients, while evaluating safety profiles and prognostic factors associated with clinical outcomes.
Interventions:
Read more
Participants will be randomly assigned to one of four treatment arms:
Group 1: Electric field acupuncture + Cerebrolysin Acupoint injection + acupressure massage Group 2: Electric field acupuncture + B-complex vitamin Acupoint injection + acupressure massage Group 3: Electroacupuncture + Cerebrolysin Acupoint injection + acupressure massage Group 4: Electroacupuncture + B-complex vitamin Acupoint injection + acupressure massage The intervention duration is 30 days.
- Conditions
- Ischemic Stroke, Hemiplegia, Neurogenic Dysphagia
- Being tested
- Electro-Field Acupuncture, Electro-Acupuncture, Cerebrolysin, B complex vitamin, Acupressure Massage
- Keywords
- Electro - acupuncture, Acupressure, Acupoint injection, Motor Rehabilitation, neurogenic dysphagia
- Medical subject headings
- Ischemic Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-Field AcupunctureDevice
Electro-field acupuncture will be administered according to the standardized study procedure using predefined acupuncture points and electrical stimulation parameters.
Electro-AcupunctureDevice
Electro-acupuncture will be administered according to the standardized study procedure using predefined acupuncture points and electrical stimulation parameters.
CerebrolysinDrug
Cerebrolysin will be administered by acupoint injection according to the standardized study protocol.
B complex vitaminDrug
B complex vitamin will be administered by acupoint injection according to the standardized study protocol.
Acupressure MassageOther
Acupressure massage will be administered as background therapy to all participants according to the standardized treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of the effect on motor function recovery in post-acute stroke patients | Experimental | Not described Receives: Device: Electro-Field Acupuncture; Device: Electro-Acupuncture; Drug: Cerebrolysin; Drug: B complex vitamin; Other: Acupressure Massage |
| Evaluation of the therapeutic effect on dysphagia in post-acute stroke patients | Experimental | Not described Receives: Device: Electro-Field Acupuncture; Device: Electro-Acupuncture; Drug: Cerebrolysin; Drug: B complex vitamin; Other: Acupressure Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment score for motor function in post-acute stroke patients
Motor function will be assessed using the Fugl-Meyer Assessment (FMA). The FMA motor function score ranges from 0 to 100, with higher scores indicating better motor function. The primary outcome is the change in FMA motor function score from baseline (Day 0) to Day 15 and Day 30.
Measured: Baseline (Day 0) to Day 15 and Day 30
Secondary outcomes (1)
Change in Gugging Swallowing Screen (GUSS) score for swallow function in post-acute stroke patients
Dysphagia will be assessed using the Gugging Swallowing Screen (GUSS), a 24-item clinical swallowing assessment. The total GUSS score ranges from 0 to 20, with a maximum score of 20. Higher scores indicate better swallowing function and less severe dysphagia, while lower scores indicate greater swallowing impairment. The change in GUSS score from baseline to Day 15 and Day 30 will be evaluated.
Measured: Baseline (Day 0) to Day 15 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Hospital of Acupuncture, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MSc.MD Nguyen Thi Ngoc Linh, National Hospital of Acupuncture, Vietnam
- Investigators
- Thanh Van Tran, MD, Associate Professor, Principal investigator, National Hospital of Acupuncture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846488
- Sponsor's protocol ID
- VN01.026
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. Individual participant data will not be shared outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating Electroacupuncture, Acupoint Injection, and Acupressure Massage for Motor and Swallowing Rehabilitation in Patients With Post-Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07846488
- Acronym / sponsor ID
- VN01.026
- Conditions
- Ischemic Stroke, Hemiplegia, Neurogenic Dysphagia
- Keywords
- Electro - acupuncture, Acupressure, Acupoint injection, Motor Rehabilitation, neurogenic dysphagia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- National Hospital of Acupuncture, VietnamUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To assess the therapeutic efficacy of combined electroacupuncture (or electric field acupuncture), hydroacupuncture (Cerebrolysin or B-complex vitamins), and acupressure massage in restoring motor function and treating dysphagia in post-acute ischemic stroke patients, while evaluating safety profiles and prognostic factors associated with clinical outcomes.
Interventions:
Participants will be randomly assigned to one of four treatment arms:
Group 1: Electric field acupuncture + Cerebrolysin Acupoint injection + acupressure massage Group 2: Electric field acupuncture + B-complex vitamin Acupoint injection + acupressure massage Group 3: Electroacupuncture + Cerebrolysin Acupoint injection + acupressure massage Group 4: Electroacupuncture + B-complex vitamin Acupoint injection + acupressure massage The intervention duration is 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evaluation of the effect on motor function recovery in post-acute stroke patients | Experimental | Device: Electro-Field Acupuncture, Device: Electro-Acupuncture, Drug: Cerebrolysin, Drug: B complex vitamin, Other: Acupressure Massage |
| Evaluation of the therapeutic effect on dysphagia in post-acute stroke patients | Experimental | Device: Electro-Field Acupuncture, Device: Electro-Acupuncture, Drug: Cerebrolysin, Drug: B complex vitamin, Other: Acupressure Massage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Cerebral venous infarction, hemorrhagic transformation of cerebral infarction.
- Stage 3-4 heart failure, cerebral vascular malformations, cerebral air embolism, chronic obstructive pulmonary disease (COPD).
- Respiratory failure requiring endotracheal intubation, impaired consciousness.
- Concurrent systemic or neuropsychiatric conditions: tuberculosis, psychiatric disorders, HIV/AIDS, epilepsy, esophageal stricture, pyloric stenosis.
- Patients who have not received Cerebrolysin treatment during the acute phase.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electro-Field AcupunctureElectro-field acupuncture will be administered according to the standardized study procedure using predefined acupuncture points and electrical stimulation parameters. | Device | Evaluation of the effect on motor function recovery in post-acute stroke patients, Evaluation of the therapeutic effect on dysphagia in post-acute stroke patients |
| Electro-AcupunctureElectro-acupuncture will be administered according to the standardized study procedure using predefined acupuncture points and electrical stimulation parameters. | Device | Evaluation of the effect on motor function recovery in post-acute stroke patients, Evaluation of the therapeutic effect on dysphagia in post-acute stroke patients |
| CerebrolysinCerebrolysin will be administered by acupoint injection according to the standardized study protocol. | Drug | Evaluation of the effect on motor function recovery in post-acute stroke patients, Evaluation of the therapeutic effect on dysphagia in post-acute stroke patients |
| B complex vitaminB complex vitamin will be administered by acupoint injection according to the standardized study protocol. | Drug | Evaluation of the effect on motor function recovery in post-acute stroke patients, Evaluation of the therapeutic effect on dysphagia in post-acute stroke patients |
| Acupressure MassageAcupressure massage will be administered as background therapy to all participants according to the standardized treatment protocol. | Other | Evaluation of the effect on motor function recovery in post-acute stroke patients, Evaluation of the therapeutic effect on dysphagia in post-acute stroke patients |
Primary outcome
Change in Fugl-Meyer Assessment score for motor function in post-acute stroke patients
Time frame: Baseline (Day 0) to Day 15 and Day 30
Motor function will be assessed using the Fugl-Meyer Assessment (FMA). The FMA motor function score ranges from 0 to 100, with higher scores indicating better motor function. The primary outcome is the change in FMA motor function score from baseline (Day 0) to Day 15 and Day 30.
1 secondary outcome
Change in Gugging Swallowing Screen (GUSS) score for swallow function in post-acute stroke patients
Time frame: Baseline (Day 0) to Day 15 and Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. No. Individual participant data will not be shared outside the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thanh Van Tran, MD, Associate Professor principal investigator
National Hospital of Acupuncture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electro-Field Acupuncture, Electro-Acupuncture and Cerebrolysin in people with Ischemic Stroke and Hemiplegia, run by National Hospital of Acupuncture, Vietnam 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 0 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 29 Sep 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. 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 Ngoc Linh Thi Nguyen, MD, MSc (+84358961018, nguyenthingoclinh.bs249@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment score for motor function in post-acute stroke patients (time frame: Baseline (Day 0) to Day 15 and Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.