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Clinical Trials/NCT02889016
NCT02889016
Recruiting
Not Applicable

Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS

Stanford University1 site in 1 country500 target enrollmentMarch 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Acute-Onset Neuropsychiatric Syndrome
Sponsor
Stanford University
Enrollment
500
Locations
1
Primary Endpoint
EEG patterns
Status
Recruiting
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
March 2028
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Frankovich

Clinical Associate Professor

Stanford University

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
  • No psychiatric diagnosis

Exclusion Criteria

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

Outcomes

Primary Outcomes

EEG patterns

Time Frame: Through study completion, up to 12 years

The 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.

Cerebral blood flow

Time Frame: Through study completion, up to 12 years

The investigators will report results of altered cerebral blood flow from patients with PANS.

Rapid Eye Movement (REM) motor disinhibition

Time Frame: Through study completion, up to 12 years

The 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 Outcomes

  • Global Impairment Scores(Every 2-4 weeks for up to 12 years)
  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)(Every 2-4 weeks for up to 12 years)
  • Caregiver Burden Inventory(Every 2-4 weeks for up to 12 years)
  • Neurological findings(Every 2-4 weeks for up to 12 years)
  • Columbia Impairment Scale(Every 2-4 weeks for up to 12 years)

Study Sites (1)

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