NCT06811935

PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study

Feasibility of a Study to Determine the Incidence and Natural History of Children With Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The objective of the Pediatric Epidemiological Data and Incidence (PEDI) PANDAS study is to demonstrate the feasibility of enrollment and retention of subjects in a study to determine the incidence and natural history of children with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) with regard to spectrum, course and outcome. The investigators aim to demonstrate they can recruit and retain 85% of children who are eligible for this study. Eligible children are those who fit criteria for PANS and Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS). Each child will be followed for one year.

Detailed description

Specific Aim 1: To establish proof-of-concept of prospectively determining the incidence of PANDAS/PANS and the role of Group A streptococcus (GAS) in this group of disorders. Specific Aim 1a: To prospectively identify and enroll children with PANDAS and PANS in geographically distinct populations of children in the US in order to determine the incidence and spectrum of these disorders. Specific Aim 1b: To determine the role of GAS in new onset PANDAS/PANS. Specific Aim 2a: To establish proof-of-concept for studying the clinical course and outcome over the first year of treatment prospectively in children identified through the EHR in a primary care population. Specific Aim 2b: To augment the number of children identified and establish proof-of-concept for studying the clinical course and outcome over the first year of treatment. Investigators will prospectively enroll children recently diagnosed with PANDAS/PANS in our local specialty clinics (not included within our primary care population) within four months of symptom onset.

Conditions

• PANS
• PANDAS

Timeline

• Start date: 2025-02-17
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-02-06
• Last updated: 2026-01-27

Locations

2 sites across 1 country: United States