Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS

PANDAS Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02889016
• Other study ID #: 26922
• Status: Recruiting
• Phase: N/A
• First received: August 22, 2016
• Last updated: October 5, 2016
• Start date: March 2013
• Est. completion date: March 2028

Study information

• Verified date: October 2016
• Source: Stanford University
• Contact: Joanne Cheung
• Email: pansresearch[@]stanford.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral blood flow	The investigators will report results of altered cerebral blood flow from patients with PANS.	Through study completion, up to 12 years	No
Primary	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	No
Primary	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	No
Secondary	Global Impairment Scores	All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.	Every 2-4 weeks for up to 12 years	No
Secondary	Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)	All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.	Every 2-4 weeks for up to 12 years	No
Secondary	Columbia Impairment Scale	All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.	Every 2-4 weeks for up to 12 years	No
Secondary	Caregiver Burden Inventory	All data will be obtained through the review of medical records, which are created during the routine clinical care of patients.	Every 2-4 weeks for up to 12 years	No
Secondary	Neurological findings	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.	Every 2-4 weeks for up to 12 years	No