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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 11/6/2025 | Other Identifier | UW Madison | |
| A536756 | Other Identifier | UW Madison | |
| 1R21MH138881-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
Specific 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.
Specific Aim 1b: To determine the role of GAS in new onset PANDAS/PANS.
Specific Aim 2a: To establish proof-of-concept for studying the clinical course and outcome over the first year of treatment prospectively in children identified through the EHR in a primary care population.
Specific Aim 2b: To augment the number of children identified and establish proof-of-concept for studying the clinical course and outcome over the first year of treatment. Investigators will prospectively enroll children recently diagnosed with PANDAS/PANS in our local specialty clinics (not included within our primary care population) within four months of symptom onset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with PANS or PANDAS | This cohort will include participants from an In Primary Care Group where the patient is a current member of the primary care population at either UW Health or Dartmouth Health and an External to Primary Care Group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eligible Participants Enrolled | 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. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Retained at 12 months | 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. | up to 12 months |
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Inclusion Criteria (All participants):
Inclusion Criteria (In primary care group only):
Pediatric patient who is a current member of the primary care population at either UW Health or Dartmouth Health
Abrupt onset of symptoms (within 7 days) occurring in the past 3 months. Willing to come in-person for at least the baseline visit.
Suspected 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:
AND (C) symptoms not better explained by another medical or neurologic disorder
PANDAS
Inclusion Criteria - External to Primary Care Group ONLY:
Exclusion Criteria (all participants):
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Children between the ages of 3 and 17 years with PANS or PANDAS.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pediatric Clinical Research Coordination | Contact | (608) 228-4940 | researchnurses@pediatrics.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ellen R Wald, MD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03766 | United States |
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| ID | Term |
|---|---|
| C537163 | Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections |
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When possible, a research only blood sample will be collected, and serum will be saved for future use and possible sharing (In Primary Care participants only). 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.
| UW School of Medicine and Public Health | Recruiting | Madison | Wisconsin | 53792 | United States |
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