Refining mUltiple Artificial intelliGence strateGies for Automatic Pain Assessment Investi
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 wil
| Condition(s) | Chronic Pain, Cancer Pain, Neuropathic Pain, Pain Assessment |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: * Adults (≥18 years old) with chronic pain, defined according to IASP and ICD-11 as pain that persists or recurs for more than three months. * Diagnosed with either: * Chronic primary pain (e.g., fibromyalgia, irritable bowel syndrome, chronic headaches) * Chronic secondary non-cancer pain (e.g., low back pain, osteoarthritis, post-surgical pain) * Chronic cancer-related pain (due to cancer or its treatment) * Ability to understand the study procedures and provide written informed consent. Exclusion Criteria: * Current treatment with psychotropic drugs or presence of active psychiatric disorders (e.g., psychosis, major depression). * Known history of alcohol or substance abuse. * Pregnancy or breastfeeding. * Age under 18 years. * Inability to provide informed consent ( |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Valentina Cerrone |
| Locations | Salerno, Italy, Italy |
| Start date | 2025-05-06 |
| NCT ID | NCT07038434 |
| Official listing | https://clinicaltrials.gov/study/NCT07038434 |