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 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT05558566
Eligibility Criteria:
Inclusion Criteria:
* Boys and girls, 10 to 16 years of age
* A current diagnosis of Tourette Syndrome (TS) or chronic tic disorder (CTD), with active tics that can be executed without head movement, and a YGTSS score of at least 13 (for TS participants) or at least 12 (for CTD participants)
* Currently stable medication treatment and no planned changes in medication for the duration of the study.
* Family residence within 2 hours of Yale Medical Center with ability and willingness to attend assessment and fMRI visits.
* Children and their parents are expected to be able to speak and understand spoken English in order to participate in a clinical assessment of TS and related psychopathology.
* Subjects will be free of: 1) metal medical implants or braces, 2) pregnancy, and will have 3) a body weight of less than 250 lbs. and 4) no claustrophobia.
Exclusion Criteria:
* Intelligence quotient below 80
* Current diagnosis of autism spectrum disorder, bipolar or psychotic disorder or current suicidality
* Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder
* Recently initiated psychotherapy. Participation in the study will not be allowed within 8 weeks of the initiation of psychotherapy. Ongoing, concurrent psychotherapy (that was initiated at least 8 weeks previously) for the child will be allowed, but parents will be asked not to initiate any new psychotherapy for the child during the study
* Subjects may also be excluded after the first MR scan if we are unable to localize the two regions in their brain that are used as targets for the active and control neurofeedback conditions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
16 Years
Study:
NCT05558566
Study Brief:
Protocol Section:
NCT05558566