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:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT06364605
Eligibility Criteria:
Inclusion Criteria:
* Having provided (by the subject or the parent/guardian) consent to be contacted through one of the recruitment channels established by the Italian Institute of Technology or voluntary enrollment;
* Signature of the informed consent (by the subject or the parent/guardian);
* Absence of other disabilities/conditions/comorbidities that would prevent participation and/or ensure patient safety during the execution of the tests and/or guarantee the quality/reliability of the data. This point is acquired through Informed Consent, in the section expressly acknowledging the following reasons for ineligibility to participate in the study: tactile hypersensitivity (specifically assessing equipment tolerance), taking neuroactive drugs and substances and having taken them in the last six months, comorbidity with another pathology;
* Being affected, to the best of their knowledge, by pathologies of the central nervous system, and having experienced epileptic episodes, even minor ones, and convulsive crises in general, even in childhood;
* The participating subjects may have typical or atypical development (i.e., group with visual disability). In the case of visual impairment, the disability should be congenital (from birth) or late onset. Furthermore, the following requirements must be met: subjects with visual disabilities must be classified according to current diagnostic rules, with visual problems present from birth or occurring later, with residual vision ranging from 0.5-1.3 LogMAR in the case of low vision or lower than 1.3 LogMAR in the case of blindness;
* Age range required for each phase and configuration: Blind adults (≥ 18 years old):
Phase 1; Phase 2; Phase 3; Typical adults (≥ 18 years old): Phase 1; Phase 2; Phase 3; Blind minors (3 months \< age \< 18 years old): All phases; Typical minors (3 months \< age \< 18 years old): All phases; Adequate cognitive capacity for age. In particular, recognized scales such as the WISC9 scale will be used as a reference parameter to assess cognitive capacity.
Exclusion Criteria:
* Additional disabilities besides visual impairment (e.g., individuals who are both visually and hearing impaired);
* Absence of the signature on the informed consent form or incomplete consent regarding acknowledgment of the incompatibilities for participation in the study;
* IQ values below the threshold of normality according to one of the recognized international scales;
* Preterm birth.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Months
Study:
NCT06364605
Study Brief:
Protocol Section:
NCT06364605