Clinical Trial: Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title:

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 Summary: 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.
Sponsor: Stanford University

Current Primary Outcome:

• 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.
• 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.
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Global Impairment Scores [ Time Frame: 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.
• Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: 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.
• Columbia Impairment Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: August 22, 2016
Date Started: March 2013
Date Completion: March 2028
Last Updated: October 5, 2016
Last Verified: October 2016