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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT06261450
Eligibility Criteria:
Inclusion Criteria:
Eligibility criteria for FXS participants will include:
* age between 7 and 55 years, molecular diagnosis of FXS,
* intelligence quotient (IQ) \<70,
* aberrant behavior questionnaire score (ABC-C) \> 20,
* \<3 psychoactive drugs, drug stable for \> 3 months.
Eligibility criteria for the control group:
* 18 and 55 years old,
* be in good general health, with no history of neurological or psychiatric disorders.
Eligibility Criteria for all Participants:
* A minimum weight of 60 kg;
* no history of liver problems (A complete blood profile to measure liver enzyme levels (bilirubin, aspartate aminotransferase (AST), argininosuccinate lyase (ASL), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)) will be obtained before randomization for all participants).
Exclusion Criteria:
* The presence of an absolute contraindication to the use of TMS and MRI / MRS (ie presence of metal in the head).
* Individuals with ALT / ASL levels greater than 3 times the upper normal baseline, or if bilirubin exceeds 2 times the upper baseline,
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
55 Years
Study:
NCT06261450
Study Brief:
Protocol Section:
NCT06261450