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

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.

NCT Number	NCT07038434
Lead Sponsor	Valentina Cerrone Collaborators: University of Salerno, Italy, Federico II University
Conditions	Chronic Pain, Cancer Pain, Neuropathic Pain, Pain Assessment
Enrollment	200 participants
Start Date	2025-05-06
Primary Completion	2025-12 (estimated)
Study Completion	2026-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-26