Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS

NCT02889016 | Recruiting

• 1 other identifier: 26922
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

PANS; PANDAS

Outcome Measures

Primary Outcomes (3)

• Cerebral blood flow

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

  Through study completion, up to 12 years

• EEG patterns

  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.

  Through study completion, up to 12 years

• Rapid Eye Movement (REM) motor disinhibition

  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.

  Through study completion, up to 12 years

Secondary Outcomes (5)

• 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

• Columbia Impairment Scale

  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

Study Arms (2)

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

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The investigators to enroll 500 children with PANS/PANDAS and 100 healthy controls. Children's parents will also be enrolled to report information about their children as well as their own caregiver burden. The 500 patients with PANS will meet diagnostic criteria. These patients are targeted because this study is seeking to specifically assess the immunologic and neurological markers of PANS.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305-5906, United States

RECRUITING

Related Publications (3)

• Swedo SE, Leckman JF, Rose NR (2012) From Research Subgroup to Clinical Syndrome: Modifying the PANDAS Criteria to Describe PANS (Pediatric Acute-onset Neuropsychiatric Syndrome). Pediatr Therapeut 2:113. doi: 10.4172/2161-0665.1000113

  BACKGROUND

• Chang K, Frankovich J, Cooperstock M, Cunningham MW, Latimer ME, Murphy TK, Pasternack M, Thienemann M, Williams K, Walter J, Swedo SE; PANS Collaborative Consortium. Clinical evaluation of youth with pediatric acute-onset neuropsychiatric syndrome (PANS): recommendations from the 2013 PANS Consensus Conference. J Child Adolesc Psychopharmacol. 2015 Feb;25(1):3-13. doi: 10.1089/cap.2014.0084. Epub 2014 Oct 17.

  PMID: 25325534 BACKGROUND

• Murphy TK, Gerardi DM, Leckman JF. Pediatric acute-onset neuropsychiatric syndrome. Psychiatr Clin North Am. 2014 Sep;37(3):353-74. doi: 10.1016/j.psc.2014.06.001.

  PMID: 25150567 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells (PBMCs) are collected from patients during flares and remissions. Samples will be used for genome-wide association studies (GWAS), time-of-flight mass spectrometry (CyTOF), TCR analyses, antibody profiling, and monocyte characterizations.

MeSH Terms

Conditions

Pediatric acute-onset neuropsychiatric syndrome; Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections

Central Study Contacts

Joanne Cheung

CONTACT

pansresearch@stanford.edu

Ellen Spartz

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 5, 2016
• Study Start: March 1, 2013
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 6, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)