Study on Pediatric Autoimmune Neuropsychiatric Disorders Linked to Streptococcus

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

This study is looking at how common certain neuropsychiatric disorders are in children aged 3-17 and how they might be linked to a specific type of bacteria called Group A streptococcus.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 3 Years to 17 Years
• Sex: All
• Sponsor: University of Wisconsin, Madison (Academic / other)
• Locations: 2 sites (Lebanon, New Hampshire and 1 other locations)
• Trial ID: NCT06811935 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the incidence and natural history of Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) and Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS) in children aged 3-17. The researchers will prospectively enroll children from diverse geographic locations in the US and follow them for one year to evaluate the role of Group A streptococcus in these disorders. The study seeks to achieve an 85% retention rate of participants throughout the study period.

Who should consider this trial

Good fit: Ideal candidates are children aged 3-17 who have experienced a sudden onset of neuropsychiatric symptoms and have a suspected or confirmed diagnosis of PANS or PANDAS.

Not a fit: Patients who do not meet the age criteria or do not have a diagnosis of PANS or PANDAS may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of PANS and PANDAS, leading to improved diagnosis and treatment strategies for affected children.

How similar studies have performed: While this study is focused on the incidence and natural history of PANS/PANDAS, similar studies have shown promise in understanding autoimmune neuropsychiatric disorders, indicating potential for success.

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 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

Where this trial is running

Lebanon, New Hampshire and 1 other locations

• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
• UW School of Medicine and Public Health — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Ellen R Wald, MD — UW School of Medicine and Public Health
• Study coordinator: Pediatric Clinical Research Coordination

Conditions PANS; PANDAS