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Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02889016
Enrollment
500
Registered
2016-09-05
Start date
2013-03-31
Completion date
2028-03-31
Last updated
2016-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

PANS, PANDAS

Brief summary

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.

Interventions

None listed

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Children with PANS 1. Age 1-18 at onset of PANS 2. 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. 3. Patients must live within 90 miles of Stanford University and have a new onset of PANS illness 4. Patients must have an established pediatrician within 90 miles of Stanford University for 3 years. * Healthy Controls 1. Age 4-18 2. No psychiatric diagnosis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Cerebral blood flowThrough study completion, up to 12 yearsThe investigators will report results of altered cerebral blood flow from patients with PANS.
EEG patternsThrough study completion, up to 12 yearsThe investigators will report results of abnormal EEG patterns from patients with PANS. All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
Rapid Eye Movement (REM) motor disinhibitionThrough study completion, up to 12 yearsThe investigators will report results of REM motor disinhibition from polysomnography studies. All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.

Secondary

MeasureTime frameDescription
Caregiver Burden InventoryEvery 2-4 weeks for up to 12 yearsAll data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
Global Impairment ScoresEvery 2-4 weeks for up to 12 yearsAll data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
Neurological findingsEvery 2-4 weeks for up to 12 yearsThe investigators will report data from neurological exam findings, including milk maid grip, chorea, choreiform movements of arms and legs, apraxia, overflow dystonia, truncal instability, piano-playing fingers, glabellar sign, etc. All data will be obtained through the review of medical records, which are created during the routine clinical care of patients. These results will be aggregated to report the number of participants with abnormal neurological findings.
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)Every 2-4 weeks for up to 12 yearsAll data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
Columbia Impairment ScaleEvery 2-4 weeks for up to 12 yearsAll data will be obtained through the review of medical records, which are created during the routine clinical care of patients.

Countries

United States

Contacts

Primary ContactJoanne Cheung
pansresearch@stanford.edu
Backup ContactEllen Spartz

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026