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NCT Number: NCT02889016

Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS

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.

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Key information

Conditions

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

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Palo Alto, California, 94305-5906, United States

Location status: Recruiting

Location contact

Joanne Cheung

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ellen Spartz

CONTACT

Joanne Cheung

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2013
Primary completion
2028
Study completion
2028
First posted
Sep 5, 2016
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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