Recruiting

Autoimmune Neuropsychiatric Disorder

Sponsor:

University of Wisconsin, Madison

Code:

NCT06811935

Conditions

PANS

PANDAS

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06811935

Start date

Feb 17, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria (All participants):

  • 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

Inclusion Criteria (In primary care group only):

  • 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:

1. Anxiety
2. Emotional lability and/or depression
3. Irritability, aggression and/or severe oppositional behaviors
4. Developmental regression
5. Deterioration in school performance
6. Sensory or motor abnormalities, including heightened sensitivity to sensory stimuli, hallucinations, dysgraphia, complex motor, and/or vocal tics
7. 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

  • PANDAS

  • Presence of OCD and/or tic disorder
  • Pre-pubertal onset of symptoms (i.e., 3-12 years old)
  • Episodic course characterized by very acute and severe onset and dramatic symptom exacerbations
  • Neurologic abnormalities present during symptom exacerbations-motoric hyperactivity and adventitious movements
  • Temporal relationships between group A streptococcus (GAS) infections and symptom exacerbations

Inclusion Criteria - External to Primary Care Group ONLY:

  • Abrupt onset of symptoms (within 7 days) occurring in the past 4 months.
  • Confirmed diagnosis of PANS or PANDAS based on published criteria (see above).

Exclusion Criteria (all participants):

  • 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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Percentage of Eligible Participants Enrolled [ Time Frame: up to 12 months ]

Central Contacts and Locations

Central contacts

Pediatric Clinical Research Coordination

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

Locations

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Principal Investigator:

Juliette Madan, MD, MS

UW School of Medicine and Public Health

Recruiting

Madison, Wisconsin, United States, 53792

Principal Investigator:

Ellen R Wald, MD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-01-27.