Actively Recruiting
Refining mUltiple Artificial intelliGence strateGies for Automatic Pain Assessment Investigations: RUGGI Study
Led by Valentina Cerrone · Updated on 2025-06-26
200
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
V
Valentina Cerrone
Lead Sponsor
U
University of Salerno, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Refining mUltiple Artificial intelliGence strateGies for Automatic Pain Assessment Investigations: RUGGI Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (≥18 years old) with chronic pain lasting more than three months as defined by IASP and ICD-11
- Diagnosed with chronic primary pain (e.g., fibromyalgia, irritable bowel syndrome, chronic headaches)
- Diagnosed with chronic secondary non-cancer pain (e.g., low back pain, osteoarthritis, post-surgical pain)
- Diagnosed with chronic cancer-related pain due to cancer or its treatment
- Able to understand study procedures and provide written informed consent
You will not qualify if you...
- Currently treated with psychotropic drugs or having active psychiatric disorders (e.g., psychosis, major depression)
- Known history of alcohol or substance abuse
- Pregnant or breastfeeding
- Under 18 years old
- Unable to provide informed consent due to cognitive impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
Salerno, Italy, Italy, 84131
Actively Recruiting
Research Team
M
Marco Cascella, MD, PhD
CONTACT
V
Valentina Cerrone, RN, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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