NCT07038434

Refining mUltiple Artificial intelliGence strateGies for Automatic Pain Assessment Investigations: RUGGI Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Valentina Cerrone · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-center, non-profit, observational-interventional study aims to develop artificial intelligence (AI) models for the automatic assessment of chronic pain (APA - Automatic Pain Assessment). The study will enroll adult patients with chronic pain of various origins (oncologic and non-oncologic). Participants will undergo multidimensional evaluations that include clinical assessments, self-report questionnaires, bio-signal collection (e.g., EEG, EDA, HRV, GSR, PPG), and facial expression analysis via infrared thermography and video recordings. The primary objective is to calibrate and test machine learning and deep learning models to recognize and predict the presence and severity of pain using multimodal data inputs. Secondary objectives include evaluating the effectiveness of pain treatments, assessing quality of life, and developing a standardized APA dataset for future research. All data collection procedures are non-invasive and safe, and include tools like wearable sensors and standardized neurocognitive tests. The study is approved by the Italian Ethics Committee (Comitato Etico Territoriale Campania 2) and complies with GDPR and EU AI regulations.

Detailed description

This study, titled "Refining mUltiple artificial intelliGence strateGies for automatic pain assessment Investigations" (RUGGI), explores the integration of AI in chronic pain evaluation. Pain is a multidimensional and subjective experience, and conventional assessment methods often rely solely on self-reported scales. This introduces the risk of over- or under-treatment. To overcome this limitation, the study leverages multimodal data-including physiological signals, facial expressions, and linguistic analysis-to build models capable of objectively assessing pain intensity and characteristics. The primary aim is to calibrate predictive models (e.g., Support Vector Machines, Random Forest, Convolutional Neural Networks, YOLO architectures, and MLPs) that can recognize pain patterns using supervised and unsupervised learning. Bio-signals (EEG, HRV, GSR, EMG), infrared thermography (HIRA system), and prosodic-linguistic features will be analyzed. Data will be collected during structured timepoints: baseline (rest), Stroop test execution, and follow-up. Patients are recruited based on chronic pain diagnosis per IASP and ICD-11 criteria. Inclusion criteria include age ≥18 and informed consent. The study foresees a target enrollment of approximately 200 patients within 6 months. Data will be processed following a rigorous AI pipeline, including preprocessing, feature extraction, dimensionality reduction, and cross-validation (k-fold with grid search optimization). Outcome measures include the Area Under the Curve (AUC), sensitivity, specificity, F1 score, and model explainability (via SHAP, LIME). Secondary outcomes include assessing patient-reported quality of life, evaluating analgesic strategies, and generating a public-use APA dataset. All procedures are compliant with Good Clinical Practice (GCP), GDPR, and EU Artificial Intelligence Act (Reg. 2024/1689). The study is conducted at the University Hospital "San Giovanni di Dio e Ruggi d'Aragona" in Salerno, Italy.

Conditions

• Chronic Pain
• Cancer Pain
• Neuropathic Pain
• Pain Assessment

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Multimodal AI-Based Pain Assessment	A non-invasive, multimodal diagnostic procedure combining self-reported pain scales (NRS, DN-4, BPI), wearable biosignal acquisition (EDA, EMG, HRV, EEG), facial thermography (HIRA system), video-based facial expression analysis, linguistic interview, and the Stroop Test. Data are used to train and validate machine learning models for automatic pain assessment in chronic pain patients.

Timeline

• Start date: 2025-05-06
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2025-06-26
• Last updated: 2025-06-26

Locations

1 site across 1 country: Italy