Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS): Clinical Characterization and Prospective Course

This study is a brief (3 month) longitudinal study following children between the ages of 4-16 years old who have been diagnosed with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). Parents and children (who are at a 2nd grade reading level) will complete questionnaires online or in person weekly for 3 months. Additionally, parents will track their child's symptoms 3 times/week using a mobile application for 3 months. The investigators are hoping to begin to characterize the longitudinal trajectory of neuropsychiatric symptoms in children with PANS. Additionally, the study will seek to identify baseline demographic and clinical characteristics (e.g., gender, recent onset versus chronic course, GAS versus other triggers) that predict severity of baseline neuropsychiatric symptoms and predict change in symptoms over time.

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Key information

Conditions

PANS PANDAS Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

English-speaking boys and girls ages 4-16 years
Abrupt onset of OCD or severely restricted food intake
At least 2 equally abrupt-onset concurrent neuropsychiatric symptoms from the following 7 categories: anxiety, emotional lability/depression, irritability/aggression/severely oppositional behaviors, behavioral/developmental regression, deterioration in school performance, sensory or motor abnormalities (e.g. tics), somatic symptoms (e.g., urinary, sleep)
Neuropsychiatric symptoms are not better explained by a known neurological or medical disorder.

Exclusion criteria

Too unstable psychiatrically or medically to participate safely in the protocol, per clinical judgment of the Principal Investigator or Co-Investigator

Treatment and study plan

No intervention

Other

No intervention; observation only

Primary outcomes

Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Compliance

Time frame: Week 12

Investigators will report overall compliance rates (percentage of completed questionnaires) for the Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale.
Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Agreement

Time frame: Week 12

Investigators will also report agreement between parent and child Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale total scores across the study. Agreement will be reported using correlations.
Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale Predictors

Time frame: Week 12

Investigators will report items from the baseline Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) Symptom Rating Scale that predict symptom severity across the study using a regression analysis.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: May 11, 2020
Registry last updated: May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed