Ischemia StrokeZMT-StrokeEANCT07107958
Electroacupuncture-Induced Changes in Tongue Features in Early Stroke Patients Using ZMT-1A Imaging System
A study testing Electroacupuncture in people with Ischemia Stroke and Electro-acupuncture, run by Dr Nguyen Ngo Le Minh Anh MD, PhD at 3 sites in Vietnam.
Trial summary
This prospective clinical study aims to evaluate changes in tongue characteristics before and after a four-week course of electroacupuncture in patients undergoing early rehabilitation following ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemia Stroke, Electro-acupuncture
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesVietnam
- Study dates
- 1 May 2025to 10 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of any age (no upper or lower age limit).
- Diagnosis of ischemic stroke confirmed by neuroimaging (CT or MRI).
- Currently in the early recovery phase, defined as 2 days to 3 months after stroke onset.
- Stable vital signs and deemed clinically suitable for rehabilitation and electroacupuncture.
- Ability to communicate effectively and follow treatment instructions.
- Provides written informed consent to participate in the study.
Who cannot join
- Diagnosis of hemorrhagic stroke or stroke of non-ischemic origin.
- Severe cognitive deficits or global aphasia that prevents participation or assessment.
- Serious comorbid conditions such as end-stage heart failure, malignancies, or renal failure.
- Presence of electronic implants (e.g., pacemakers) or other contraindications to electroacupuncture.
- Enrollment in another interventional clinical trial within the preceding 30 days.
Trial locations and contacts
3 sites in 1 country.
Vietnam3 sites
Ho Chi Minh City Traditional Medicine Hospital
Ho Chi Minh City, 700000
University Medical Center Ho Chi Minh City - Campus 3
Ho Chi Minh City, 700000
Ho Chi Minh City Hospital for Rehabilitation and Orthopedics
Ho Chi Minh City, 70000
About this study
Official title: Assessment of Tongue Diagnosis Changes Before and After Electroacupuncture in Early Rehabilitation of Ischemic Stroke Patients Using ZMT-1A Tongue Analysis System
This prospective clinical study aims to evaluate changes in tongue characteristics before and after a four-week course of electroacupuncture in patients undergoing early rehabilitation following ischemic stroke. Electroacupuncture is widely used in Vietnam as part of traditional medicine-based stroke rehabilitation, yet few studies have objectively quantified its effects on tongue diagnosis.
The study uses the ZMT-1A Tongue Imaging System, an automated diagnostic tool developed in China and currently used at the University of Medicine and Pharmacy at Ho Chi Minh City. The system enables standardized tongue image acquisition and analysis of key features such as tongue body color, tongue shape, coating color, and coating texture.
Read more
A total of 200 participants with confirmed ischemic stroke in the early recovery stage (from day 2 to 3 months post-stroke) will be recruited from three hospitals. Each participant will receive electroacupuncture treatment according to standardized protocols for 4 weeks. Tongue images will be collected before and after the intervention. The primary outcome is the change in tongue characteristics. Secondary outcomes include changes in functional status as measured by the Barthel Index and the correlation between tongue changes and functional improvement.
This study aims to provide evidence for the clinical relevance of tongue diagnosis in stroke rehabilitation and to explore its role in monitoring treatment response to electroacupuncture.
Read the detailed description
Tongue diagnosis is one of the four traditional diagnostic methods in Chinese and Vietnamese traditional medicine. It reflects the physiological and pathological conditions of the internal organs and is considered an objective and noninvasive indicator for syndrome differentiation. However, tongue diagnosis has historically relied on practitioner experience, which may be subject to environmental conditions and inter-observer variability.
In recent years, automated tongue diagnostic systems (ATDS) have been developed to standardize and objectify tongue assessment. One such system, ZMT-1A, is equipped with a controlled lighting environment, a calibrated camera, and built-in algorithms for analyzing tongue body and coating features. This study uses the ZMT-1A system to capture and analyze tongue images of stroke patients undergoing electroacupuncture treatment.
Ischemic stroke is a leading cause of long-term disability worldwide. Early rehabilitation within the first 3 months post-stroke is essential for functional recovery. In Vietnam, electroacupuncture is integrated into standard care for stroke rehabilitation and is believed to regulate qi and blood, restore meridian circulation, and support organ function. Yet, few studies have examined the effects of electroacupuncture on tongue characteristics, which may reflect internal changes and treatment response.
This single-group pre-post interventional study will recruit 385 patients diagnosed with ischemic stroke in the early recovery stage (day 2 to 3 months post-onset) from three clinical sites: the Ho Chi Minh City Hospital for Rehabilitation and Orthopedics, the Ho Chi Minh City Traditional Medicine Hospital, and University Medical Center - Campus 3. All participants will receive a 4-week course of electroacupuncture based on national standardized acupoint protocols for stroke.
Data collection will include: (1) tongue images before and after treatment, captured using the ZMT-1A system; and (2) functional assessment using the Barthel Index. The main outcome measure is the change in tongue characteristics, specifically tongue body color, shape, coating color, and coating texture. Secondary outcomes include improvement in Barthel Index score and correlation between tongue features and functional recovery.
The study was approved by the Ethics Committee in Biomedical Research at the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 2862/ĐHYD-HĐĐĐ, dated October 10, 2024). The findings of this study may support the clinical validity of tongue diagnosis and promote the use of image-based diagnostic systems in traditional medicine research and practice.
- Conditions
- Ischemia Stroke, Electro-acupuncture
- Being tested
- Electroacupuncture
- Keywords
- Electroacupuncture,, Ischemic Stroke, Stroke Rehabilitation, Tongue Diagnosis, ZMT-1A, Barthel Index
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
Electroacupuncture is applied using standardized stroke rehabilitation protocols. Needles are inserted at acupoints including LI15 (Jianyu), LI11 (Quchi), TE5 (Waiguan), LI4 (Hegu), GB30 (Huantiao), ST36 (Zusanli), and GB34 (Yanglingquan), and connected to an electroacupuncture device delivering alternating current stimulation at 10-20 Hz. Each session lasts 15-20 minutes, performed once daily, 5 days per week, for 4 weeks. The intervention follows Vietnam's national traditional medicine guidelines for post-stroke recovery.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture for Ischemic Stroke Rehabilitation | Experimental | Participants with ischemic stroke in the early recovery stage (day 2 to 3 months post-onset) will receive a standardized 4-week course of electroacupuncture, using acupoints based on national clinical guidelines. Electroacupuncture is performed 1 session per day, 5 days per week, targeting acupoints such as LI15 (Jianyu), LI11 (Quchi), TE5 (Waiguan), LI4 (Hegu), GB30 (Huantiao), ST36 (Zusanli), and GB34 (Yanglingquan).
Tongue images will be collected using the ZMT-1A Tongue Imaging System before and after the intervention. Functional outcomes will be assessed using the Barthel Index Receives: Procedure: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tongue diagnosis characteristics before and after electroacupuncture treatment
This outcome assesses the changes in tongue features including:
- Tongue body color
- Tongue shape
- Tongue coating color
- Tongue coating texture
Images are captured pre- and post-electroacupuncture using the ZMT-1A Tongue Imaging System. The system automatically classifies tongue features into standardized categories (25-parameter classification system).
Unit of Measure:
Proportion (%) of participants showing improvement or change in each tongue characteristic (ordinal scale)
Measured: Baseline and after 4 weeks of electroacupuncture
Secondary outcomes (1)
Change in Barthel Index score before and after electroacupuncture treatment
This outcome evaluates the change in functional independence using the Barthel Index, a validated 10-item scale assessing activities of daily living (ADLs). Scores range from 0 (completely dependent) to 100 (fully independent).
Unit of Measure:
Mean Barthel Index score (scale: 0-100)
Measured: Baseline and after 4 weeks of electroacupuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 May 2025
- Primary completion25 Jul 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, pre-post interventional study evaluating changes in tongue features and functional outcomes before and after electroacupuncture treatment in patients with ischemic stroke.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Nguyen Ngo Le Minh Anh MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Nguyen Ngo Le Minh Anh MD, PhD, University of Science Ho Chi Minh City
- Investigators
- Minh-Anh Nguyen Ngo Le, M.D., Ph.D., Principal investigator, Faculty of Traditional Medicine, UMP, HCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107958
- Sponsor's protocol ID
- ZMT-StokeEA2025
- Acronym
- ZMT-StrokeEA
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tongue Diagnosis Changes Before and After Electroacupuncture in Early Rehabilitation of Ischemic Stroke Patients Using ZMT-1A Tongue Analysis System
- ClinicalTrials.gov ID
- NCT07107958
- Acronym / sponsor ID
- ZMT-StrokeEA / ZMT-StokeEA2025
- Conditions
- Ischemia Stroke, Electro-acupuncture
- Keywords
- Electroacupuncture,, Ischemic Stroke, Stroke Rehabilitation, Tongue Diagnosis, ZMT-1A, Barthel Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dr Nguyen Ngo Le Minh Anh MD, PhDUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 6 Aug 2025 (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.
This prospective clinical study aims to evaluate changes in tongue characteristics before and after a four-week course of electroacupuncture in patients undergoing early rehabilitation following ischemic stroke. Electroacupuncture is widely used in Vietnam as part of traditional medicine-based stroke rehabilitation, yet few studies have objectively quantified its effects on tongue diagnosis.
The study uses the ZMT-1A Tongue Imaging System, an automated diagnostic tool developed in China and currently used at the University of Medicine and Pharmacy at Ho Chi Minh City. The system enables standardized tongue image acquisition and analysis of key features such as tongue body color, tongue shape, coating color, and coating texture.
A total of 200 participants with confirmed ischemic stroke in the early recovery stage (from day 2 to 3 months post-stroke) will be recruited from three hospitals. Each participant will receive electroacupuncture treatment according to standardized protocols for 4 weeks. Tongue images will be collected before and after the intervention. The primary outcome is the change in tongue characteristics. Secondary outcomes include changes in functional status as measured by the Barthel Index and the correlation between tongue changes and functional improvement.
This study aims to provide evidence for the clinical relevance of tongue diagnosis in stroke rehabilitation and to explore its role in monitoring treatment response to electroacupuncture.
Detailed description
Tongue diagnosis is one of the four traditional diagnostic methods in Chinese and Vietnamese traditional medicine. It reflects the physiological and pathological conditions of the internal organs and is considered an objective and noninvasive indicator for syndrome differentiation. However, tongue diagnosis has historically relied on practitioner experience, which may be subject to environmental conditions and inter-observer variability.
In recent years, automated tongue diagnostic systems (ATDS) have been developed to standardize and objectify tongue assessment. One such system, ZMT-1A, is equipped with a controlled lighting environment, a calibrated camera, and built-in algorithms for analyzing tongue body and coating features. This study uses the ZMT-1A system to capture and analyze tongue images of stroke patients undergoing electroacupuncture treatment.
Ischemic stroke is a leading cause of long-term disability worldwide. Early rehabilitation within the first 3 months post-stroke is essential for functional recovery. In Vietnam, electroacupuncture is integrated into standard care for stroke rehabilitation and is believed to regulate qi and blood, restore meridian circulation, and support organ function. Yet, few studies have examined the effects of electroacupuncture on tongue characteristics, which may reflect internal changes and treatment response.
This single-group pre-post interventional study will recruit 385 patients diagnosed with ischemic stroke in the early recovery stage (day 2 to 3 months post-onset) from three clinical sites: the Ho Chi Minh City Hospital for Rehabilitation and Orthopedics, the Ho Chi Minh City Traditional Medicine Hospital, and University Medical Center - Campus 3. All participants will receive a 4-week course of electroacupuncture based on national standardized acupoint protocols for stroke.
Data collection will include: (1) tongue images before and after treatment, captured using the ZMT-1A system; and (2) functional assessment using the Barthel Index. The main outcome measure is the change in tongue characteristics, specifically tongue body color, shape, coating color, and coating texture. Secondary outcomes include improvement in Barthel Index score and correlation between tongue features and functional recovery.
The study was approved by the Ethics Committee in Biomedical Research at the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 2862/ĐHYD-HĐĐĐ, dated October 10, 2024). The findings of this study may support the clinical validity of tongue diagnosis and promote the use of image-based diagnostic systems in traditional medicine research and practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, pre-post interventional study evaluating changes in tongue features and functional outcomes before and after electroacupuncture treatment in patients with ischemic stroke.
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture for Ischemic Stroke Rehabilitation | Experimental | Procedure: ElectroacupunctureParticipants with ischemic stroke in the early recovery stage (day 2 to 3 months post-onset) will receive a standardized 4-week course of electroacupuncture, using acupoints based on national clinical guidelines. Electroacupuncture is performed 1 session per day, 5 days per week, targeting acupoints such as LI15 (Jianyu), LI11 (Quchi), TE5 (Waiguan), LI4 (Hegu), GB30 (Huantiao), ST36 (Zusanli), and GB34 (Yanglingquan). Tongue images will be collected using the ZMT-1A Tongue Imaging System before and after the intervention. Functional outcomes will be assessed using the Barthel Index |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults of any age (no upper or lower age limit).
- Diagnosis of ischemic stroke confirmed by neuroimaging (CT or MRI).
- Currently in the early recovery phase, defined as 2 days to 3 months after stroke onset.
- Stable vital signs and deemed clinically suitable for rehabilitation and electroacupuncture.
- Ability to communicate effectively and follow treatment instructions.
Key exclusion criteria (5 listed)
- Diagnosis of hemorrhagic stroke or stroke of non-ischemic origin.
- Severe cognitive deficits or global aphasia that prevents participation or assessment.
- Serious comorbid conditions such as end-stage heart failure, malignancies, or renal failure.
- Presence of electronic implants (e.g., pacemakers) or other contraindications to electroacupuncture.
- Enrollment in another interventional clinical trial within the preceding 30 days.
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 |
|---|---|---|
| ElectroacupunctureElectroacupuncture is applied using standardized stroke rehabilitation protocols. Needles are inserted at acupoints including LI15 (Jianyu), LI11 (Quchi), TE5 (Waiguan), LI4 (Hegu), GB30 (Huantiao), ST36 (Zusanli), and GB34 (Yanglingquan), and connected to an electroacupuncture device delivering alternating current stimulation at 10-20 Hz. Each session lasts 15-20 minutes, performed once daily, 5 days per week, for 4 weeks. The intervention follows Vietnam's national traditional medicine guidelines for post-stroke recovery. | Procedure or surgery | Electroacupuncture for Ischemic Stroke Rehabilitation |
Primary outcome
Change in tongue diagnosis characteristics before and after electroacupuncture treatment
Time frame: Baseline and after 4 weeks of electroacupuncture
This outcome assesses the changes in tongue features including: * Tongue body color * Tongue shape * Tongue coating color * Tongue coating texture Images are captured pre- and post-electroacupuncture using the ZMT-1A Tongue Imaging System. The system automatically classifies tongue features into standardized categories (25-parameter classification system). Unit of Measure: Proportion (%) of participants showing improvement or change in each tongue characteristic (ordinal scale)
1 secondary outcome
Change in Barthel Index score before and after electroacupuncture treatment
Time frame: Baseline and after 4 weeks of electroacupuncture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Minh-Anh Nguyen Ngo Le, M.D., Ph.D. principal investigator
Faculty of Traditional Medicine, UMP, HCMC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Ischemia Stroke and Electro-acupuncture, run by Dr Nguyen Ngo Le Minh Anh MD, PhD at 3 sites 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tongue diagnosis characteristics before and after electroacupuncture treatment (time frame: Baseline and after 4 weeks of electroacupuncture). 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 28 Aug 2026.