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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT03510156
Eligibility Criteria:
Inclusion Criteria:
1. Child has a confirmed diagnosis of FXS (\>200 CGG repeats on the FMR1 gene with evidence of aberrant methylation)
2. Child is male, between the ages of 3-10 years old
3. Child is reported to show self-injury, property destruction and/or aggression on at least a daily basis
4. The caregiver agrees to keep any therapies that the child receives (i.e., medications or other treatments) as stable as possible throughout involvement in the study
5. The family has a high-speed internet connection at home or lives in an area with 4G network coverage
6. Availability for one-hour daily telemedicine treatment sessions
7. Availability for in-home assessment totaling 8 hours across two consecutive days
Exclusion Criteria:
1. The child or caregiver has significant sensory impairments (e.g., blindness or deafness)
2. Non-English speaking
3. The child receives Applied Behavior Analysis services in excess of five hours per week
4. The child has a significant neurological condition (e.g., frequent seizures, brain injury, Tourette's syndrome) that would preclude participation
5. The child or caregiver has significant mobility issues
6. The child is currently participating in another research study that would preclude participation in the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
3 Years
Maximum Age:
10 Years
Study:
NCT03510156
Study Brief:
Protocol Section:
NCT03510156