Biomarkers for PANS: Diagnosing and Tracking Pediatric Neuropsychiatric Symptoms

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 observational study will identify neurophysiological, molecular, genetic, and metabolomic biomarkers linked to onset, progression, and treatment response in pediatric PANS. All enrolled participants will undergo overnight polysomnography and EEG, along with analyses such as 1H-NMR and miRNA sequencing, at baseline and after treatment. Sleep patterns, EEG features, and other biomarker data will be analyzed to define objective associations with clinical status using standard criteria. The goal is to improve diagnostic accuracy and enable more targeted therapeutic strategies. The study is conducted across multiple Italian centers with a lead role at the University of Cagliari.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* (I) PANS diagnosis made according to 2010 NIH criteria

Exclusion Criteria (for the PANS group):

* (I) onset of specific rheumatologic or immunologic diseases;
* (II) presence of a diagnosed cancer or other severe medical illnesses;
* (III) active treatment with steroidal or non-steroidal anti-inflammatory drugs

The control group must include children without autoimmune diseases, neurodevelopmental or psychiatric disorders, and with adequate academic performance and functional level.

Where it's running

• Azienda Ospedaliera Universitaria Gaetano Martino
  Messina, Messina, Italy Recruiting
• Centro di Medicina del Sonno, SC Neurologia, AOU Cagliari
  Cagliari, Cagliari, Italy Active not recruiting
• Università degli Studi eCampus
  Novedrate, Co, Italy Active not recruiting
• UOC Neuropsichiatria
  Troina, Enna, Italy Active not recruiting
• Dipartimento di Scienze Psicologiche, Pedagogiche, dell¿Esercizio Fisico e della Formazione
  Palermo, Palermo, Italy Active not recruiting

Study contacts

• Study coordinator: Monica MF Puligheddu, MD, PHD
• Email: puligheddu@unica.it
• Phone: 070 5109 6016

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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.