Study on Pediatric Autoimmune Neuropsychiatric Disorders Linked to Streptococcus
Official title: Feasibility of a Study to Determine the Incidence and Natural History of Children With Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)
Run by University of Wisconsin, Madison · NCT06811935 · Data updated 2026-11-12
This study is looking at how common certain neuropsychiatric disorders are in children aged 3-17 and how they might be linked to a specific type of bacteria called Group A streptococcus.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 17 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 2 sites (Lebanon, New Hampshire and 1 other locations) |
| Status | Recruiting |
| Started | February 17, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT06811935 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3-17 who have experienced a sudden onset of neuropsychiatric symptoms and have a suspected or confirmed diagnosis of PANS or PANDAS.
✕Probably not a fit
Patients who do not meet the age criteria or do not have a diagnosis of PANS or PANDAS may not benefit from this study.
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 aims to assess the incidence and natural history of Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) and Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS) in children aged 3-17. The researchers will prospectively enroll children from diverse geographic locations in the US and follow them for one year to evaluate the role of Group A streptococcus in these disorders. The study seeks to achieve an 85% retention rate of participants throughout the study period.
Why it matters
Potential benefit: If successful, this study could enhance understanding of PANS and PANDAS, leading to improved diagnosis and treatment strategies for affected children.
How similar studies have gone: While this study is focused on the incidence and natural history of PANS/PANDAS, similar studies have shown promise in understanding autoimmune neuropsychiatric disorders, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States Recruiting -
UW School of Medicine and Public Health
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Ellen R Wald, MD — UW School of Medicine and Public Health
- Study coordinator: Pediatric Clinical Research Coordination
- Email: researchnurses@pediatrics.wisc.edu
- Phone: (608) 228-4940
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Investigating markers in children with sudden-onset neuropsychiatric symptoms
This study is testing if certain biological markers in children with sudden neuropsychiatric symptoms can help us understand Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) better.
-
Biomarkers for PANS: Diagnosing and Tracking Pediatric Neuropsychiatric Symptoms
This study tests a panel of biomarkers to help diagnose PANS in children and see if they reflect disease course and response to treatment.
-
A platform for collecting health data on ME/CFS and Long Covid
This study is trying to collect health information from adults with ME/CFS and Long Covid to help researchers better understand these conditions and improve future treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.