Refining multiple AI strategies for automatic pain assessment (RUGGI)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, observational-interventional project will enroll about 200 adults with chronic pain from oncologic and non-oncologic causes and collect multimodal, non-invasive data including EEG, HRV, GSR/EDA, EMG, PPG, infrared thermography, facial video, and self-report questionnaires. Recordings occur at structured timepoints (baseline rest, during a Stroop task, and follow-up) with wearable sensors and synchronized video to capture physiological and behavioral responses. Data will be preprocessed, features extracted, and machine learning pipelines (SVMs, random forests, CNNs, YOLO, MLPs) trained with cross-validation and grid-search optimization to recognize presence and severity of pain. The project also intends to produce a standardized, anonymized APA dataset and explore links between objective signals, treatment response, and quality of life.

Why it matters

Who can join: the full rules

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).

Where it's running

• Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
  Salerno, Italy, Italy Recruiting

Study contacts

• Principal investigator: Marco Cascella, MD, PhD — University of Salerno
• Study coordinator: Marco Cascella, MD, PhD
• Email: mcascella@unisa.it
• Phone: +39 089 672428

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.