RECRUITING

PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06811935

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.

Ages Eligible for Study:3 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Pediatric Clinical Research Coordination

CONTACT

(608) 228-4940

researchnurses@pediatrics.wisc.edu

Principal Investigator

Ellen R Wald, MD

PRINCIPAL_INVESTIGATOR

UW School of Medicine and Public Health

Study Locations (Sites)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766

United States

UW School of Medicine and Public Health

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02

Study Completion Date2027-06

Study Record Updates

Study Start Date2025-02

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

PANS
PANDAS