Electroacupuncture-Induced Changes in Tongue Features in Early Stroke Patients Using ZMT-1A Imaging System

NCT07107958 | Active Not Recruiting

• 1 other identifier: ZMT-StokeEA2025
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 3

Brief 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. 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 385 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.

Conditions

Ischemia Stroke; Electro-acupuncture

Keywords

Electroacupuncture,; Ischemic Stroke; Stroke Rehabilitation; Tongue Diagnosis; ZMT-1A; Barthel Index

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline and after 4 weeks of electroacupuncture

Secondary Outcomes (1)

• Change in Barthel Index score before and after electroacupuncture treatment

  Baseline and after 4 weeks of electroacupuncture

Other Outcomes (1)

• Correlation between changes in tongue features and changes in Barthel Index score

  Baseline and after 4 weeks of electroacupuncture

Study Arms (1)

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

Procedure: Electroacupuncture

Interventions

Electroacupuncture PROCEDURE

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.

Electroacupuncture for Ischemic Stroke Rehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Nguyen Ngo Le Minh Anh MD, PhD: lead

Study Sites (3)

Ho Chi Minh City Traditional Medicine Hospital

Ho Chi Minh City, 700000, Vietnam

Location

University Medical Center Ho Chi Minh City - Campus 3

Ho Chi Minh City, 700000, Vietnam

Location

Ho Chi Minh City Hospital for Rehabilitation and Orthopedics

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

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

Study Officials

• Minh-Anh Nguyen Ngo Le, M.D., Ph.D.

  Faculty of Traditional Medicine, UMP, HCMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Not applicable. This study is open-label and does not involve blinding of participants or assessors
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, Faculty of Traditional Medicine

Model Details: This is a single-arm, pre-post interventional study evaluating the effect of electroacupuncture on tongue features and functional outcomes in ischemic stroke patients.

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 6, 2025
• Study Start: May 1, 2025
• Primary Completion: July 25, 2025
• Study Completion: July 29, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

VN (3)