Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-03 @ 10:02 PM
Study NCT ID:
NCT07107958
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electroacupuncture-Induced Changes in Tongue Features in Early Stroke Patients Using ZMT-1A Imaging System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015671', 'term': 'Electroacupuncture'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Not applicable. This study is open-label and does not involve blinding of participants or assessors'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a single-arm, pre-post interventional study evaluating the effect of electroacupuncture on tongue features and functional outcomes in ischemic stroke patients.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 385}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation between changes in tongue features and changes in Barthel Index score', 'timeFrame': 'Baseline and after 4 weeks of electroacupuncture', 'description': 'This outcome measures the statistical correlation between:\n\n* The degree of change in tongue characteristics (ordinal scores based on ZMT-1A analysis)\n* The improvement in Barthel Index score\n* The strength of association will be evaluated using Pearson or Spearman correlation coefficients, depending on data distribution.\n\nUnit of Measure:\n\nCorrelation coefficient (r-value), p-value'}], 'primaryOutcomes': [{'measure': 'Change in tongue diagnosis characteristics before and after electroacupuncture treatment', 'timeFrame': 'Baseline and after 4 weeks of electroacupuncture', 'description': 'This outcome assesses the changes in tongue features including:\n\n* Tongue body color\n* Tongue shape\n* Tongue coating color\n* Tongue coating texture\n\nImages 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).\n\nUnit of Measure:\n\nProportion (%) of participants showing improvement or change in each tongue characteristic (ordinal scale)'}], 'secondaryOutcomes': [{'measure': 'Change in Barthel Index score before and after electroacupuncture treatment', 'timeFrame': 'Baseline and after 4 weeks of electroacupuncture', 'description': '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).\n\nUnit of Measure:\n\nMean Barthel Index score (scale: 0-100)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electroacupuncture,', 'Ischemic Stroke', 'Stroke Rehabilitation', 'Tongue Diagnosis', 'ZMT-1A', 'Barthel Index'], 'conditions': ['Ischemia Stroke', 'Electro-acupuncture']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nA 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.\n\nThis 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.', 'detailedDescription': '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.\n\nIn 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.\n\nIschemic 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.\n\nThis 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.\n\nData 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults of any age (no upper or lower age limit).\n* Diagnosis of ischemic stroke confirmed by neuroimaging (CT or MRI).\n* Currently in the early recovery phase, defined as 2 days to 3 months after stroke onset.\n* Stable vital signs and deemed clinically suitable for rehabilitation and electroacupuncture.\n* Ability to communicate effectively and follow treatment instructions.\n* Provides written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Diagnosis of hemorrhagic stroke or stroke of non-ischemic origin.\n* Severe cognitive deficits or global aphasia that prevents participation or assessment.\n* Serious comorbid conditions such as end-stage heart failure, malignancies, or renal failure.\n* Presence of electronic implants (e.g., pacemakers) or other contraindications to electroacupuncture.\n* Enrollment in another interventional clinical trial within the preceding 30 days.'}, 'identificationModule': {'nctId': 'NCT07107958', 'acronym': 'ZMT-StrokeEA', 'briefTitle': 'Electroacupuncture-Induced Changes in Tongue Features in Early Stroke Patients Using ZMT-1A Imaging System', 'organization': {'class': 'OTHER', 'fullName': 'University of Science Ho Chi Minh City'}, 'officialTitle': 'Assessment of Tongue Diagnosis Changes Before and After Electroacupuncture in Early Rehabilitation of Ischemic Stroke Patients Using ZMT-1A Tongue Analysis System', 'orgStudyIdInfo': {'id': 'ZMT-StokeEA2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electroacupuncture for Ischemic Stroke Rehabilitation', 'description': '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).\n\nTongue 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', 'interventionNames': ['Procedure: Electroacupuncture']}], 'interventions': [{'name': 'Electroacupuncture', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['Electroacupuncture for Ischemic Stroke Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Ho Chi Minh City Traditional Medicine Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}, {'zip': '700000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'University Medical Center Ho Chi Minh City - Campus 3', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}, {'zip': '70000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Ho Chi Minh City Hospital for Rehabilitation and Orthopedics', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Minh-Anh Nguyen Ngo Le, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Traditional Medicine, UMP, HCMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Nguyen Ngo Le Minh Anh MD, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer, Faculty of Traditional Medicine', 'investigatorFullName': 'Dr Nguyen Ngo Le Minh Anh MD, PhD', 'investigatorAffiliation': 'University of Science Ho Chi Minh City'}}}}