TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls

Official title

Application of Artificial Intelligence for Precision Medicine in TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls

Overview

Myasthenia gravis primarily results from neuromuscular junction dysfunction and damage, leading to chronic muscle weakness. While combined traditional and Western medicine treatments are now common, TCM tongue diagnosis remains a simple and practical clinical method. However, results can vary among different practitioners. Therefore, you are interested in using scientific methods to compare TCM tongue diagnosis images between patients with myasthenia gravis and healthy individuals to aid in diagnosis.

Detailed description

In Taiwan, the prevalence of severe myasthenia gravis is approximately 14 per 100,000 people, with an incidence rate of about 2 per 100,000 people.

Currently, combined traditional and Western medicine treatments are very popular. In Traditional Chinese Medicine (TCM), tongue diagnosis is a simple and practical clinical method, focusing on aspects such as the tongue body, coating, color, and sublingual veins. Clinical evaluation often relies on the experience and knowledge of TCM practitioners, which can be influenced by subjective factors like diagnostic skills. As a result, findings may vary depending on the observer.

To improve diagnostic accuracy, using scientific methods to support TCM tongue diagnosis can provide more precise information for practitioners and enhance the clinical application value of tongue diagnosis in TCM.

Interventions

• Device Heart Rate Variability,HRV - ANSWatch
  Please have the participant lie down and rest for 10 minutes, and remove any metallic items from their body. Next, put on the wrist-worn monitor, and avoid moving during the monitoring process. The device will emit a sound when the monitoring session is complete.
• Device Traditional Chinese Medicine Tongue Imaging
  Use a camera to capture images of the tongue, and then have a Traditional Chinese Medicine (TCM) practitioner perform the diagnosis based on these images.

Primary outcome measures

• What are the differences in tongue diagnosis in traditional Chinese medicine between the disease group and the healthy population? [Time frame: 2025/01/18 (4th week)]

Secondary outcome measures (1)

• Observe the differences in physical constitution and tongue diagnosis between patients with myasthenia and healthy people. [Time frame: 2025/01/18 (4th week)]

Eligibility criteria

Inclusion criteria

• Diagnosed with myasthenia gravis by a physician.
• Able to understand and communicate in Mandarin and Taiwanese.
• Cognitively alert and without a diagnosis of psychiatric disorders.
• Willing to undergo tongue imaging and instrument measurements.

Exclusion criteria

• Patients with severe organ diseases.
• Hearing loss patients who are unable to complete the questionnaire.
• Patients with aphasia who are unable to complete the questionnaire.
• Have eaten food or drinks that can easily contaminate tongue coating within 2 hours.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Taiwan · 1 center

• Yi Ting Yeh — New Taipei City

Identifiers

NCT: NCT06754020 · 20221019R

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗