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Search / Trial NCT06364605

MySpace: the Role of Vision in Representing Space

Launched by ISTITUTO ITALIANO DI TECNOLOGIA · Apr 9, 2024

Trial Information

Current as of November 06, 2025

Enrolling by invitation

Keywords

Blindness Infants Spatial Representations Eeg Child Development Medical Device

ClinConnect Summary

MySpace is a science study from the Italian Institute of Technology that looks at how vision helps people understand where things are in space. Researchers want to see how people—especially infants and children with and without vision—use sounds and touch to judge movement, distance, and location. The study has four phases: the first three involve behavioral tasks and brain measurements to understand how spatial thinking develops, and the fourth phase will test a new multisensory rehabilitation device called the iReach to help improve sensorimotor skills in very young children (ages 3 to 36 months) who are blind or have low vision. The project is conducted in Genoa, Italy, and expects about 720 participants over several years, with completion targeted around the end of 2025.

Eligible people include children from 3 months up to older ages and adults who can give consent (or have a parent/guardian consent for minors). Key inclusion criteria are the ability to participate and no other disabilities that would interfere with safety or data quality; people with visually impaired (congenital or later-onset) vision are welcome, as long as they meet the defined vision levels and can complete the study procedures. Exclusions include having disabilities beyond vision, not being able to consent, significant cognitive concerns, epilepsy history, or preterm birth. The tests are non-invasive and may include listening and movement tasks, eye-tracking, EEG brain measurements, and, in some phases, MRI. In Phase 4, infants may try the iReach device in clinic or home settings, with follow-up assessments about four months later to see if any gains persist.

Gender

ALL

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.

About Istituto Italiano Di Tecnologia

The Istituto Italiano di Tecnologia (IIT) is a leading research institution in Italy, dedicated to advancing scientific knowledge and technological innovation in various fields, including life sciences, robotics, and nanotechnology. With a strong emphasis on interdisciplinary collaboration, IIT fosters cutting-edge research and development aimed at enhancing human health and quality of life. The institute actively engages in clinical trials and studies, leveraging its expertise to translate scientific discoveries into practical applications. By promoting a culture of innovation and excellence, IIT plays a pivotal role in driving progress in healthcare and biomedical research on both national and international stages.

Locations

Genova, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported