Study for Pediatric Autoimmune Neuropsychiatric Disorders
PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study
Recruiting
Observational Study
PANSPANDAS
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
3 – 17
Sex
Any
Study type
Observational
Participants needed
30 (estimated)
Sponsor
University of Wisconsin, Madison · Other
Who this trial is looking for
This trial is looking for children aged 3 to 17 who have symptoms of Pediatric Autoimmune Neuropsychiatric Syndrome (PANS) or Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS). Participants will need to be followed for one year and complete various study activities.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 3 and 17 years old
I speak and understand English
My family plans to be followed within UW Health or Dartmouth Health for at least a year
I have abrupt symptoms that started within the last 3 months
I have been diagnosed with PANS or PANDAS
You may not be able to join if
I have a history of tics, OCD, or food restriction/avoidance that started before this investigation
I currently have symptoms of Pica
I have participated in this study before
I am not able to complete study activities in English
The investigator says I am not suitable for this study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
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Eligibility Criteria
Inclusion Criteria (All participants):
* 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
Inclusion Criteria (In primary c…
Inclusion Criteria (All participants):
* 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
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:
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.
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
Inclusion Criteria - External to Primary Care Group ONLY:
* 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).
Exclusion Criteria (all participants):
* 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
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