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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT06385535
Eligibility Criteria:
Inclusion Criteria:
* 8 to 12 years old child who meets the criteria for diagnosis of a persistent tic disorder (e.g., persistent motor/vocal tic disorder or Tourette's disorder; i.e., engages in motor and/or vocal tics that have been present for at least one year)
* The child's tics initially onset before age 10.
* The child currently engages in at least four different motor and/or vocal tics per minute, on average, during a 10-minute observation period.
* The child has a minimum Total Tic Severity Score of 20 on the Yale Global Tic Severity Scale (10 for motor or vocal tics only)
* If the child is on tic-suppressing or psychotropic medication, the dose has been stable for at least 6 weeks with no changes or planned changes in medication status during the study period.
* Parent and child read and speak fluent English.
* The parent is 18+ years of age.
* Access to a private computer with high-speed internet access and private setting.
Exclusion Criteria:
* If, based on the assessment of the study investigators, the child has any serious psychiatric or neurological condition that would interfere with study participation (e.g., unmanaged attention-deficit hyperactivity disorder)
* The child has a self- or parent-reported history of, or is reasonably suspected to have or meet criteria for, functional neurological symptom disorder.
* The child has received more than two sessions of behavioral treatment for tics for which tic suppression was a primary component.
* The child has a Total Tic Severity Score of 40+ on the Yale Global Tic Severity Scale (20+ for motor/vocal tics only).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT06385535
Study Brief:
Protocol Section:
NCT06385535