RECRUITING

PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study

Description

The objective of the Pediatric Epidemiological Data and Incidence (PEDI) PANDAS study is to demonstrate the feasibility of enrollment and retention of subjects in a study to determine the incidence and natural history of children with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) with regard to spectrum, course and outcome. The investigators aim to demonstrate they can recruit and retain 85% of children who are eligible for this study. Eligible children are those who fit criteria for PANS and Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS). Each child will be followed for one year.

Conditions

PANSPANDAS
Talk to us

Related Conditions:

PANSPANDAS

Study Overview

On this page

Study Details

Study overview

The objective of the Pediatric Epidemiological Data and Incidence (PEDI) PANDAS study is to demonstrate the feasibility of enrollment and retention of subjects in a study to determine the incidence and natural history of children with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) with regard to spectrum, course and outcome. The investigators aim to demonstrate they can recruit and retain 85% of children who are eligible for this study. Eligible children are those who fit criteria for PANS and Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS). Each child will be followed for one year.

Feasibility of a Study to Determine the Incidence and Natural History of Children With Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)

PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study

Condition
PANS
Intervention / Treatment

-

Contacts and Locations

Lebanon

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03766

Madison

UW School of Medicine and Public Health, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Child age 3-17 years old
  • * Child and their parent/guardian are able to complete all study activities in English
  • * Abrupt onset of symptoms (within 7 days) occurring in the past 3 months. Willing to come in-person for at least the baseline visit.
  • * Pediatric patient who is a current member of the primary care population at either UW Health or Dartmouth Health
  • * Potential participant's family plans to be followed within UW Health or Dartmouth Health for at least one year
  • * Suspected or confirmed diagnosis of PANS or PANDAS based on published criteria:
  • * PANS: (A) Abrupt, dramatic, overnight onset of obsessive compulsive disorder (OCD) or severely restricted food intake; (B) concurrent abrupt onset of additional severe neuropsychiatric symptoms from at least 2 of the following 7 categories:
  • 1. Anxiety
  • 2. Emotional lability and/or depression
  • 3. Irritability, aggression and/or severe oppositional behaviors
  • 4. Developmental regression
  • 5. Deterioration in school performance
  • 6. Sensory or motor abnormalities, including heightened sensitivity to sensory stimuli, hallucinations, dysgraphia, complex motor, and/or vocal tics
  • 7. Somatic signs and symptoms, including sleep disturbances, enuresis or urinary frequency consistent with a known neurologic or medical disorder.
  • * PANDAS
  • * Presence of OCD and/or tic disorder
  • * Pre-pubertal onset of symptoms (i.e., 3-12 years old)
  • * Episodic course characterized by very acute and severe onset and dramatic symptom exacerbations
  • * Neurologic abnormalities present during symptom exacerbations-motoric hyperactivity and adventitious movements
  • * Temporal relationships between group A streptococcus (GAS) infections and symptom exacerbations
  • * History of tics, OCD or food restriction/avoidance that contradicts a history of sudden onset or was present before the onset of this investigation
  • * Current symptom(s) of Pica
  • * Previous participation in the study
  • * Not suitable for study participation at the discretion of the site investigator (e.g., the child does not have verbal or cognitive ability adequate for self-report assessment)
  • * Patient or family is unable to complete the study questionnaires or procedures in English as the primary language

Ages Eligible for Study

3 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Wisconsin, Madison,

Ellen R Wald, MD, PRINCIPAL_INVESTIGATOR, UW School of Medicine and Public Health

Study Record Dates

2027-06