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Recruiting NCT02889016

Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS

— Observational Pediatric Acute-Onset Neuropsychiatric Syndrome Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections PANS PANDAS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pediatric Acute-Onset Neuropsychiatric Syndrome, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections, PANS, PANDAS. Basic parameters: 4 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study is an investigation of the neurologic, immunologic, and rheumatologic markers of Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS). PANS is a condition characterized by the abrupt, dramatic onset of obsessive compulsive disorder (OCD) and/or eating restriction accompanied by equally abrupt and severe co-morbid neuropsychiatric symptoms, which include anxiety, emotional lability, depression, irritability, aggression, oppositionality, deterioration in school performance, behavioral (developmental) regression, sensory amplification, movement abnormalities, sleep disturbance, and urinary frequency. PANS is thought to be caused by infection, inflammation, or alternate triggers that is associated with a brain response that leads to these symptoms. The purpose of this study is to examine specific neurologic, immunologic, rheumatologic, and genomic, components in children with the acute-onset of psychiatric symptoms. This research may begin to uncover a much larger story of autoimmune processes that are involved in psychiatric disorders of childhood. By better understanding the etiologic components of psychiatric phenomenon, future treatments may be better targeted to underlying causes.

Detailed description

The investigators will recruit 500 children, 1-18 years old at onset with PANS/PANDAS. They will be treatment naive and within one month of onset/exacerbation. The 500 children with PANS will be gender- and age-matched to 100 healthy children, to allow examination of immunologic, neurologic, genomic, and behavioral differences between these two groups of children.

Primary outcome measures

  • Cerebral blood flow [Time frame: Through study completion, up to 12 years]
  • EEG patterns [Time frame: Through study completion, up to 12 years]
  • Rapid Eye Movement (REM) motor disinhibition [Time frame: Through study completion, up to 12 years]
Secondary outcome measures (5)
  • Global Impairment Scores [Time frame: Every 2-4 weeks for up to 12 years]
  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [Time frame: Every 2-4 weeks for up to 12 years]
  • Columbia Impairment Scale [Time frame: Every 2-4 weeks for up to 12 years]
  • Caregiver Burden Inventory [Time frame: Every 2-4 weeks for up to 12 years]
  • Neurological findings [Time frame: Every 2-4 weeks for up to 12 years]

Eligibility criteria

Inclusion criteria

  • Children with PANS
  • Age 1-18 at onset of PANS
  • Diagnosis of PANS: abrupt onset of OCD or food restriction, and at least two of the following associated symptoms: frequent urination, worsening handwriting/cognition, inattention, anorexia, separation anxiety, oppositionality, irritability/rage outbursts, and emotional lability.
  • Patients must live within 90 miles of Stanford University and have a new onset of PANS illness
  • Patients must have an established pediatrician within 90 miles of Stanford University for 3 years.
  • Healthy Controls
  • Age 4-18
  • No psychiatric diagnosis

Exclusion criteria

  • Any neuropsychiatric illness that may obscure the clear diagnosis of PANS

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Stanford University — Palo Alto

Publications

  • Swedo SE, Leckman JF, Rose NR (2012) From Research Subgroup to Clinical Syndrome: Modifying the PANDAS Criteria to Describe PANS (Pediatric Acute-onset Neuropsychiatric Syndrome). Pediatr Therapeut 2:113. doi: 10.4172/2161-0665.1000113
  • Chang K, Frankovich J, Cooperstock M, Cunningham MW, Latimer ME, Murphy TK, Pasternack M, Thienemann M, Williams K, Walter J, Swedo SE; PANS Collaborative Consortium. Clinical evaluation of youth with pediatric acute-onset neuropsychiatric syndrome (PANS): recommendations from the 2013 PANS Consensus Conference. J Child Adolesc Psychopharmacol. 2015 Feb;25(1):3-13. doi: 10.1089/cap.2014.0084. Epub PMID 25325534
  • Murphy TK, Gerardi DM, Leckman JF. Pediatric acute-onset neuropsychiatric syndrome. Psychiatr Clin North Am. 2014 Sep;37(3):353-74. doi: 10.1016/j.psc.2014.06.001. PMID 25150567

Identifiers

NCT: NCT02889016 · 26922

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗