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 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT07044804
Eligibility Criteria:
Inclusion Criteria:
1. Italian speakers participants of both genders with the presence of a free trisomy 21 documented by karyotyping
2. Adolescents and young adults from 12 to 21 years old
3. Mental age ≥ 4 years (as assessed by Leiter-3 at baseline)
4. Scores \< 2 SD at the denomination subtest of BVL\_4-12
5. Be comprehensible to closest relatives, at least in part, exhibiting consistent speech sounds mesured by Intelligibility in Context Scale (ICS): Italian (McLeod, Harrison, \& McCormack, 2012) with a cut-off of 3.5
6. Informed consent/absent from each patient and Informed consent from their caregivers.
Exclusion Criteria:
1. The presence of any neurosensory deficits, such as hypoacusis or serious visual impairments
2. The presence of epilepsy, familiarity with epilepsy and major psychopathological disorders
3. Scores \< 10 points at the denomination subtest of BVL\_4-12
4. Ability to verbally imitate less that 7 of 10 words during an imitation screening task
5. Undergoing concomitant speech therapy or psychopharmacological therapy for cognitive or behavioral improvement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
21 Years
Study:
NCT07044804
Study Brief:
Protocol Section:
NCT07044804