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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT01569568
Eligibility Criteria:
Inclusion Criteria:
Subject inclusion criteria:
1. Patients with OTCD;
2. Age range: 7-60 years
3. Able to undergo neuroimaging safely (i.e. without presence of ferromagnetic devices)
4. Subject has a documented full scale IQ \> 70
Control participant inclusion criteria:
1. Healthy males and females without metabolic disease aged 7-60 years
2. Subject has a documented full scale IQ \> 70
Exclusion Criteria:
Subject exclusion criteria:
1. Mental retardation (i.e., Full Scale IQ\< 70)
2. Age range \<7 or \>60 years
3. Presence of ferromagnetic device(s) that preclude safe imaging
4. Pregnant female
Control exclusion criteria:
1. Subjects with a documented history of an intellectual deficit (i.e., Full Scale IQ\< 70)
2. Age range \<7 or \>60 years
3. Presence of ferromagnetic device(s) that preclude safe imaging
4. Pregnant female
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
60 Years
Study:
NCT01569568
Study Brief:
Protocol Section:
NCT01569568