Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS

Recruiting

• Conditions: Pediatric Acute-Onset Neuropsychiatric Syndrome; Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections; PANS; PANDAS

• Registration Number: NCT02889016
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-09-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-06
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EEG patterns	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	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	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 Outcome Measures

Name	Time	Method
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)	Every 2-4 weeks for up to 12 years	All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
Caregiver Burden Inventory	Every 2-4 weeks for up to 12 years	All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
Global Impairment Scores	Every 2-4 weeks for up to 12 years	All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.
Neurological findings	Every 2-4 weeks for up to 12 years	The 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.
Columbia Impairment Scale	Every 2-4 weeks for up to 12 years	All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States