"Machine Learning Analysis of Lingual Colorimetry and MADRS Anxiety-Depression Score in Acupuncture Patients" (ML_AcuTongue)

Machine Learning Analysis of Lingual Colorimetry and MADRS Score in Acupuncture Patients: a Prospective Observational Study

This observational study aims to assess the potential relationship between tongue colorimetry (using standardized photographic techniques) and anxiety-depression scores measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) in acupuncture patients. Data will be analyzed using machine learning methods to determine whether tongue color features correlate with MADRS scores, possibly contributing to a novel, non-invasive diagnostic tool for anxiety and depression assessment in clinical practice.

Participation involves only tongue photography and completion of questionnaires, without any invasive procedures or treatment modifications.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Disorders

Detailed Description

This prospective observational study investigates the correlation between lingual colorimetry, captured using readily available and standardized modern photographic tools (iPhone cameras), and anxiety-depression scores evaluated by the Montgomery-Åsberg Depression Rating Scale (MADRS) among patients attending routine acupuncture consultations.

Participants will undergo a simple and non-invasive photographic recording of their tongue using an iPhone, ensuring consistent lighting and standardized positioning to minimize variability. Simultaneously, participants will complete the MADRS questionnaire, a widely validated instrument for assessing anxiety and depression severity. No invasive procedures or therapeutic interventions beyond their usual acupuncture care will be performed.

The acquired photographic data will be analyzed using machine learning algorithms to identify potential predictive relationships between distinct colorimetric characteristics of the tongue and the MADRS scores. The objective is to determine whether lingual imaging could serve as a reliable, non-invasive biomarker or complementary diagnostic tool for assessing psychological status in clinical practice.

This approach leverages everyday technology (smartphones), promoting ease of replication and broader accessibility in clinical environments. Ultimately, findings from this study could facilitate early detection and monitoring of anxiety-depressive disorders, thus enhancing individualized patient care in complementary and integrative medicine.

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

Study Locations

• France
  • Narbonne, France, 11100
    • Recruiting
    • Cabinet Médical d'Acupuncture
    • Contact: Benoit Bataille, MD; Phone Number: +33 6 81 34 74 22; Email: b_bataille@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational monocentric study conducted in an acupuncture practice. The study aims to establish a correlation between tongue colorimetric features and MADRS scores in patients consulting for symptoms related to anxiety.

Tongue photography and MADRS assessment present no risk to participants. A non-opposition declaration for photography and consent for anonymous and confidential data analysis will be obtained.

Description

Inclusion Criteria:

• Patients aged 18 years or older
• Native French speakers
• No medical conditions or medications affecting tongue coloration
• Consulting for acupuncture with symptoms involving an anxious component

Exclusion Criteria:

• Presence of psychosis or substance abuse
• Eating or taking medication within one hour before the examination
• Refusal to complete the Montgomery-Åsberg Depression Rating Scale (MADRS) questionnaire
• Refusal to have their tongue photographed

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation using Machine Learning between Tongue Colorimetric Features and MADRS Scores	This study aims to evaluate the correlation between standardized tongue colorimetric parameters (obtained through digital photographs) and depression/anxiety scores measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Machine learning methods will be used to analyze tongue images and identify potential associations between colorimetric features and MADRS scores. Participants will be categorized into two subgroups: MADRS < 15 and MADRS ≥ 15, to assess the ability of tongue characteristics to differentiate depression severity.	Baseline (single evaluation at enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Machine Learning Analysis of Tongue Features and MADRS Scores	Density Diagram.; Partial Correlation Analysis (Train/Test Split): Relationship between tongue color and MADRS scores.; Logistic Regression Model (Train/Test); Support Vector Machine (SVM) on PCA: Model performance evaluation with ROC analysis.; Deep Learning Model: CNN applied to tongue images, classification based on color and texture.; Shapley Values Interpretation: Feature importance analysis for AI models.; Correlation Between Individual MADRS Items and Tongue Zones: Zone-by-zone statistical analysis.; MANCOVA Analysis: Multivariate analysis of covariance to assess multiple dependent variables.; CNN-based Model on Images: Direct classification of tongue features using convolutional neural networks.; Subgroup Identification via PCA (3 Components): Exploring potential depression subtypes.	Baseline (single evaluation at enrollment)

Collaborators and Investigators

• Sponsor: Dr Benoit Bataille

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Acupuncture; Artificial Intelligence; Machine Learning; MADRS; Tongue Colorimetry; Image Analysis
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: ML_AcuTongue_MADRS_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The potential sharing of IPD is currently undecided due to ethical considerations regarding the anonymization of tongue photographs. The ethics committee has highlighted the importance of ensuring that no identifiable characteristics can be traced back to participants. If a sharing plan is implemented, it will ensure strict anonymization protocols, including removing metadata, blurring any identifiable features, and restricting access to approved researchers under a confidentiality agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No