Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06899490

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation using Machine Learning between Tongue Colorimetric Features and MADRS Scores

    Time frame: Baseline (single evaluation at enrollment)

    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.

Secondary outcomes

  1. Machine Learning Analysis of Tongue Features and MADRS Scores

    Time frame: Baseline (single evaluation at enrollment)

    • 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.

Sponsors and collaborators

Lead sponsor

Dr Benoit Bataille

Other

Registry information

Official study title

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

Acronym: ML_AcuTongue

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.