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:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT03507218
Eligibility Criteria:
* INCLUSION CRITERIA:
Affected Probands (Children with PANS) will be eligible if they:
1. Are 3 to 14 years of age (initial enrollment must occur prior
2. Have a history of abrupt onset (less than 24-48 hours) of impairing OCD and/or eating restrictions.
3. Are able to travel safely to the regional medical center where the evaluations will be conducted and are able to be examined safely over a period of one or more days.
4. Assent to participate (if they are at least seven years old and have capacity to do so) and have legal guardians who consent to their minor child s participation.
5. Are under the care of a primary physician in their home community.
First-degree Relatives will be eligible if they:
1. Are a biologic parent or sibling of an affected proband.
2. Consent (or assent) to undergo study evaluations and to provide blood, microbial and genetic samples.
Children with Non-PANS Neuropsychiatric Symptoms may be enrolled if they:
1. Are 3 to 14 years of age (initial enrollment must occur prior to the participant s 15th birthday to permit prospective longitudinal evaluations)
2. Have OCD, tics, anxiety disorders, or other psychiatric symptoms, but do NOT have a history of acute symptom onset.
3. Are willing to participate in medical, psychiatric, and behavioral assessments and to provide bio-specimens including blood, urine, and microbial flora (mouth, oropharynx, and/or stool).
4. Assent to participate (if they are at least seven years old and have capacity to do so) and have legal guardians who consent to their minor child s participation.
5. Are under the care of a primary physician in their home community.
Healthy Pediatric Volunteers may be enrolled if they:
1. Are 3 to 14 years of age (initial enrollment must occur prior to the participant s 15th birthday to permit prospective longitudinal evaluations).
2. Are physically healthy and do not have psychiatric symptoms.
3. Are willing to participate in medical, psychiatric, and behavioral assessments and to provide bio-specimens including blood, urine, and microbial flora (mouth, oropharynx, and/or stool).
4. Assent to participate (if they are at least seven years old and have capacity to do so) and have legal guardians who consent to their minor child s participation.
EXCLUSION CRITERIA:
Participants will not be eligible if they:
1. Appear to the investigators to be too unstable psychiatrically or medically to participate safely in the protocol.
2. Are unwilling or unable to be evaluated and followed prospectively.
3. Have a parent/guardian who is not willing to participate at a distance through web-based or phone-based data collection.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT03507218
Study Brief:
Protocol Section:
NCT03507218