Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-01 @ 5:30 PM
Study NCT ID:
NCT06811935
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537163', 'term': 'Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'When possible, a research only blood sample will be collected, and serum will be saved for future use and possible sharing. This blood sample will be spun down and the serum separated and stored in a freezer. There will not be genetic testing done on this or any sample collected in this study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-01-31', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Eligible Participants Enrolled', 'timeFrame': 'up to 12 months', 'description': 'To demonstrate that the methods of recruitment are effective, the aim is to enroll 85 percent of children with PANS/PANDAS who meet preliminary eligibility criteria for the study.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Retained at 12 months', 'timeFrame': 'up to 12 months', 'description': 'The secondary endpoint is retention in the study. The investigators hypothesize that at the 12-month visit, 85 percent of the children who are enrolled will still be on study.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PANS', 'PANDAS']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Specific Aim 1: To establish proof-of-concept of prospectively determining the incidence of PANDAS/PANS and the role of Group A streptococcus (GAS) in this group of disorders.\n\nSpecific Aim 1a: To prospectively identify and enroll children with PANDAS and PANS in geographically distinct populations of children in the US in order to determine the incidence and spectrum of these disorders.\n\nSpecific Aim 1b: To determine the role of GAS in new onset PANDAS/PANS.\n\nSpecific Aim 2: To establish proof-of-concept for studying the clinical course and outcome over the first year of treatment prospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children between the ages of 3 and 17 years with PANS or PANDAS.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child age 3-17 years old\n* Child and their parent/guardian are able to complete all study activities in English\n* Abrupt onset of symptoms (within 7 days) occurring in the past 3 months. Willing to come in-person for at least the baseline visit.\n* Pediatric patient who is a current member of the primary care population at either UW Health or Dartmouth Health\n* Potential participant's family plans to be followed within UW Health or Dartmouth Health for at least one year\n* Suspected or confirmed diagnosis of PANS or PANDAS based on published criteria:\n\n * 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:\n\n 1. Anxiety\n 2. Emotional lability and/or depression\n 3. Irritability, aggression and/or severe oppositional behaviors\n 4. Developmental regression\n 5. Deterioration in school performance\n 6. Sensory or motor abnormalities, including heightened sensitivity to sensory stimuli, hallucinations, dysgraphia, complex motor, and/or vocal tics\n 7. Somatic signs and symptoms, including sleep disturbances, enuresis or urinary frequency consistent with a known neurologic or medical disorder.\n\nAND (C) symptoms not better explained by another medical or neurologic disorder\n\n* PANDAS\n\n * Presence of OCD and/or tic disorder\n * Pre-pubertal onset of symptoms (i.e., 3-12 years old)\n * Episodic course characterized by very acute and severe onset and dramatic symptom exacerbations\n * Neurologic abnormalities present during symptom exacerbations-motoric hyperactivity and adventitious movements\n * Temporal relationships between group A streptococcus (GAS) infections and symptom exacerbations\n\nExclusion Criteria:\n\n* History of tics, OCD or food restriction/avoidance that contradicts a history of sudden onset or was present before the onset of this investigation\n* Current symptom(s) of Pica\n* Previous participation in the study\n* 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)\n* Patient or family is unable to complete the study questionnaires or procedures in English as the primary language"}, 'identificationModule': {'nctId': 'NCT06811935', 'acronym': 'PANDAS', 'briefTitle': 'PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Feasibility of a Study to Determine the Incidence and Natural History of Children With Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)', 'orgStudyIdInfo': {'id': '2024-1009'}, 'secondaryIdInfos': [{'id': 'Protocol Version 11/22/2024', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'A536756', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '1R21MH138881-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21MH138881-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with PANS or PANDAS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Juliette Madan, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen R Wald, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UW School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Pediatric Clinical Research Coordination', 'role': 'CONTACT', 'email': 'researchnurses@pediatrics.wisc.edu', 'phone': '(608) 228-4940'}], 'overallOfficials': [{'name': 'Ellen R Wald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW School of Medicine and Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}