Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT02889016

Conditions

Pediatric Acute-Onset Neuropsychiatric Syndrome

Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections

PANS

PANDAS

Eligibility Criteria

Sex: All

Age: 4 - 18

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Pediatric Acute-Onset Neuropsychiatric Syndrome

Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections

PANS

PANDAS

Study ID

NCT02889016

Start date

Mar, 2013

Status verified date

Oct, 2016

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 18

Healthy Volunteers: Accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

PANS group

500 children, 1-18 years old at onset with a strict diagnosis of PANS/PANDAS will be recruited

Health Controls

100 healthy children age- and gender- matched to the PANS group will be recruited

Primary outcome measure

  • Cerebral blood flow [ Time Frame: Through study completion, up to 12 years ]
  • EEG patterns [ Time Frame: Through study completion, up to 12 years ]
  • Rapid Eye Movement (REM) motor disinhibition [ Time Frame: Through study completion, up to 12 years ]

Central Contacts and Locations

Central contacts

Joanne Cheung

pansresearch@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94305-5906

Contacts

Joanne Cheung

pansresearch@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Oct 6, 2016

Last verified

Oct, 2016

Keywords

  • PANS
  • PANDAS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2016-10-06.