NCT07038434 Refining mUltiple Artificial intelliGence strateGies for Automatic Pain Assessment Investigations: RUGGI Study
| NCT ID | NCT07038434 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Valentina Cerrone |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-05-06 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 (e.g., due to cognitive impairment).
Contact & Investigator
Marco Cascella, MD, PhD
PRINCIPAL INVESTIGATOR
University of Salerno
Frequently Asked Questions
Who can join the NCT07038434 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07038434 currently recruiting?
Yes, NCT07038434 is actively recruiting participants. Contact the research team at mcascella@unisa.it for enrollment information.
Where is the NCT07038434 trial being conducted?
This trial is being conducted at Salerno, Italy.
Who is sponsoring the NCT07038434 clinical trial?
NCT07038434 is sponsored by Valentina Cerrone. The principal investigator is Marco Cascella, MD, PhD at University of Salerno. The trial plans to enroll 200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.