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Search / Trial NCT06811935

PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study

Launched by UNIVERSITY OF WISCONSIN, MADISON · Jan 31, 2025

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

The PEDI Pediatric Autoimmune Neuropsychiatric Disorder Study is looking into a condition called Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) and its related disorder, Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS). The study aims to understand how common these conditions are in children and how they develop over time. Researchers want to see if they can successfully enroll and keep at least 85% of eligible children in the study for a year.

To participate, children should be between 3 and 17 years old and have recently experienced a sudden onset of symptoms, like severe anxiety or obsessive thoughts, within the last three months. They should also be patients at UW Health or Dartmouth Health and have a family plan to stay with these health systems for at least a year. If eligible, children will undergo assessments and be followed for one year to help researchers gather important information about PANS and PANDAS.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Child age 3-17 years old
  • Child and their parent/guardian are able to complete all study activities in English
  • Abrupt onset of symptoms (within 7 days) occurring in the past 3 months. Willing to come in-person for at least the baseline visit.
  • Pediatric patient who is a current member of the primary care population at either UW Health or Dartmouth Health
  • Potential participant's family plans to be followed within UW Health or Dartmouth Health for at least one year
  • * Suspected or confirmed 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
  • Exclusion Criteria:
  • 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

About University Of Wisconsin, Madison

The University of Wisconsin-Madison is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive resources, including cutting-edge facilities and a diverse pool of expert researchers, to conduct rigorous studies that address critical health challenges. The institution's focus on translating research findings into practical applications fosters the development of new treatments and interventions, ultimately contributing to improved patient outcomes and public health initiatives. As a sponsor of clinical trials, the University of Wisconsin-Madison is dedicated to upholding the highest ethical standards and ensuring participant safety throughout the research process.

Locations

Lebanon, New Hampshire, United States

Madison, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Ellen R Wald, MD

Principal Investigator

UW School of Medicine and Public Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported