Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT06811935
Eligibility Criteria:
Inclusion Criteria:
* Child age 3-17 years old
* Child and their parent/guardian are able to complete all study activities in English
* Abrupt onset of symptoms (within 7 days) occurring in the past 3 months. Willing to come in-person for at least the baseline visit.
* Pediatric patient who is a current member of the primary care population at either UW Health or Dartmouth Health
* Potential participant's family plans to be followed within UW Health or Dartmouth Health for at least one year
* Suspected or confirmed 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT06811935
Study Brief:
Protocol Section:
NCT06811935