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

NCT04382716 | Completed

• 1 other identifier: University_of_Minnesota
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PANS; PANDAS

Outcome Measures

Primary Outcomes (3)

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

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

  Week 12

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

  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.

  Week 12

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

  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.

  Week 12

Study Arms (1)

PANS participants

Other: No intervention

Interventions

No intervention OTHER

No intervention; observation only

PANS participants

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with an established or suspected diagnosis of PANS/PANDAS.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• Harris EC, Conelea CA, Shyne MT, Bernstein GA. Predictors and Prospective Course of PANS: A Pilot Study Using Electronic Platforms for Data Collection. J Child Adolesc Psychopharmacol. 2021 Mar;31(2):102-108. doi: 10.1089/cap.2020.0124. Epub 2020 Dec 31.

  PMID: 33395354 DERIVED

MeSH Terms

Conditions

Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections

Study Design

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

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 11, 2020
• Study Start: May 2, 2018
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: May 11, 2020

Record last verified: 2020-05

Locations

US (1)