PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study

NCT06811935 | Recruiting

• 4 other identifiers: 2024-1009Protocol Version 11/6/2025A5367561R21MH138881-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

PANS; PANDAS

Outcome Measures

Primary Outcomes (1)

• Percentage of Eligible Participants Enrolled

  To demonstrate that the methods of recruitment are effective, the aim is to enroll 85 percent of children with PANS/PANDAS who meet preliminary eligibility criteria for the study.

  up to 12 months

Secondary Outcomes (1)

• Percentage of Participants Retained at 12 months

  up to 12 months

Study Arms (1)

Children with PANS or PANDAS

This cohort will include participants from an In Primary Care Group where the patient is a current member of the primary care population at either UW Health or Dartmouth Health and an External to Primary Care Group.

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between the ages of 3 and 17 years with PANS or PANDAS.

You may qualify if:

• Child age 3-17 years old
• Child and their parent/guardian are able to complete all study activities in English
• Potential participant's family plans to be followed within UW Health or Dartmouth Health for at least one year
• Pediatric patient who is a current member of the primary care population at either UW Health or Dartmouth Health
• Abrupt onset of symptoms (within 7 days) occurring in the past 3 months. Willing to come in-person for at least the baseline visit.
• Suspected diagnosis of PANS or PANDAS based on published criteria:
• PANS: (A) Abrupt, dramatic, overnight onset of obsessive compulsive disorder (OCD) or severely restricted food intake; (B) concurrent abrupt onset of additional severe neuropsychiatric symptoms from at least 2 of the following 7 categories:
• Anxiety
• Emotional lability and/or depression
• Irritability, aggression and/or severe oppositional behaviors
• Developmental regression
• Deterioration in school performance
• Sensory or motor abnormalities, including heightened sensitivity to sensory stimuli, hallucinations, dysgraphia, complex motor, and/or vocal tics
• Somatic signs and symptoms, including sleep disturbances, enuresis or urinary frequency consistent with a known neurologic or medical disorder.
• AND (C) symptoms not better explained by another medical or neurologic disorder

You may not qualify if:

• History of tics, OCD or food restriction/avoidance that contradicts a history of sudden onset or was present before the onset of this investigation
• Current symptom(s) of Pica
• Previous participation in the study
• Not suitable for study participation at the discretion of the site investigator (e.g., the child does not have verbal or cognitive ability adequate for self-report assessment)
• Patient or family is unable to complete the study questionnaires or procedures in English as the primary language

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of Wisconsin, Madison: lead

Study Sites (2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

When possible, a research only blood sample will be collected, and serum will be saved for future use and possible sharing (In Primary Care participants only). This blood sample will be spun down and the serum separated and stored in a freezer. There will not be genetic testing done on this or any sample collected in this study.

MeSH Terms

Conditions

Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections

Study Officials

• Ellen R Wald, MD

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pediatric Clinical Research Coordination

CONTACT

(608) 228-4940; researchnurses@pediatrics.wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)