PANSPANDASNCT06811935
PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study
An observational study of PANS and PANDAS, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children between the ages of 3 and 17 years with PANS or PANDAS.
Who may be able to join
- Child age 3-17 years old
- Child and their parent/guardian are able to complete all study activities in English
- Potential participant's family plans to be followed within UW Health or Dartmouth Health for at least one year
- 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:
Show all 23Show fewer
- 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:
- Anxiety
- Emotional lability and/or depression
- Irritability, aggression and/or severe oppositional behaviors
- Developmental regression
- Deterioration in school performance
- Sensory or motor abnormalities, including heightened sensitivity to sensory stimuli, hallucinations, dysgraphia, complex motor, and/or vocal tics
- Somatic signs and symptoms, including sleep disturbances, enuresis or urinary frequency consistent with a known neurologic or medical disorder.
- AND (C) symptoms not better explained by another medical or neurologic 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
- Abrupt onset of symptoms (within 7 days) occurring in the past 4 months.
- Confirmed diagnosis of PANS or PANDAS based on published criteria (see above).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Juliette Madan, MD, MS
- Recruiting
UW School of Medicine and Public Health
Madison, Wisconsin, 53792
Ellen R Wald, MD
About this study
Official title: Feasibility of a Study to Determine the Incidence and Natural History of Children With Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)
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.
Read the detailed description
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.
- Medical subject headings
- Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (1)
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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start17 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PANSStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ellen R Wald, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811935
- Sponsor's protocol ID
- 2024-1009
- Other IDs
- Protocol Version 11/6/2025, A536756, 1R21MH138881-01
- Acronym
- PANDAS
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Study to Determine the Incidence and Natural History of Children With Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)
- ClinicalTrials.gov ID
- NCT06811935
- Acronym / sponsor ID
- PANDAS / 2024-1009
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children between the ages of 3 and 17 years with PANS or PANDAS.
Key inclusion criteria (23 listed)
- Child age 3-17 years old
- Child and their parent/guardian are able to complete all study activities in English
- Potential participant's family plans to be followed within UW Health or Dartmouth Health for at least one year
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Eligible Participants Enrolled
Time frame: up to 12 months
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.
1 secondary outcome
Percentage of Participants Retained at 12 months
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Yes
Related trials for PANS
RecruitingObservational study
Biomarkers for Diagnosis and Treatment Response in Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)
PANS, Pediatric Acute-Onset Neuropsychiatric Syndrome
RecruitingObservational study
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
Post-Acute COVID-19 Syndrome, ME/CFS
RecruitingObservational study
Neurobiologic, Immunologic, and Rheumatologic Markers in Youth With PANS
Pediatric Acute-Onset Neuropsychiatric Syndrome, Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellen R Wald, MD principal investigator
UW School of Medicine and Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PANS and PANDAS, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pediatric Clinical Research Coordination ((608) 228-4940, researchnurses@pediatrics.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Eligible Participants Enrolled (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.