Clinical trial NCT06364605: MySpace: the Role of Vision in Representing Space
Official title: MySpace: the Role of Vision on Perceptual Space Representation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Blindness
Visual Impairment
Keywords: blindness
infants
spatial representations
EEG
child development
medical device
Lead sponsor: Istituto Italiano di Tecnologia
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 720
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: My Space aims to identify the ontogenesis of spatial representation through cross-sectional and longitudinal studies in infants, children, and adolescents with typical and atypical development (visual impairments). The results will serve for the design and development of a novel multisensory device for sensorimotor rehabilitation in blind children from the early stages of life.

Detailed description: MySpace is an interventional neuropsychology study purely for scientific purposes, with no diagnostic or therapeutic aims. The project aims to define the role of vision in generating uni- and multi-sensory spatial representations (audio/tactile), essential for proper interaction with the surrounding environment. The project will focus on studying spatial deficits and reorganization mechanisms present in the absence of vision from the early years of development. The results will allow drawing overall conclusions on how we perceive the world and develop rehabilitative protocols to improve the quality of life of individuals with visual sensory disabilities. In detail, the project is divided into 4 macro-objectives:

* Study of the role of vision in the development of uni-sensory spatial representations (Phase 1) through experimental procedures at the behavioral and cortical levels. This phase aims to understand the specific temporal windows within which auditory and tactile spatial representations develop in visually impaired children. This phase involves infants and children in an age range from 3 months to 16 years old, with typical and atypical development (visual disabilities), as well as sighted adults and those with visual disabilities. This phase includes the use of behavioral, kinematic, and neurophysiological techniques, employing EEG systems, to provide an assessment of a participant's response to sensory stimuli. Number of participants: 50 sighted adults, 20 blind adults, 60 blind children, 100 sighted children;
* Role of vision in the development of multi-sensory spatial representations (Phase 2) The objective of Phase 2 is to define, the role of vision in the generation of audio-tactile multi-sensory representations. In this phase, both infants and children ranging from 3 months to 16 years old, with and without visual disabilities, as well as adults with and without visual disabilities, will participate. In Phase 2, experiments will be conducted using behavioral, psychophysical, and motion tracking methods. The neurophysiological architecture associated with multi-sensory integration will be studied using EEG. Number of participants: 80 sighted adults, 20 blind adults, 60 blind children, 120 sighted children;
* Neuro-imaging of spatial representation (Phase 3) Phase 3 will study the mechanisms of cortical reorganization following the absence of vision in the early years of life, particularly those concerning the visual cortex responsible for processing spatial information. This phase involves a single setup in which both adults and children ranging from 3 months to 16 years old take part. This phase hypothesizes that structural changes resulting from a visual disability may emerge during the early years of life when spatial perceptual abilities develop and cortical reorganization begins. In this phase, each participant will undergo structural MRI recording to investigate the structural changes observed during growth in both typical cases and cases of visual disability. Number of participants: 50 sighted adults, 20 blind adults, 30 blind children, 30 sighted children;
* Multi-sensory training (Phase 4) The objective of Phase 4 is the development and evaluation of multi-sensory training aimed at helping visually impaired children improve their spatial representation ability and overcome limitations due to the absence of vision. This phase involves infants with both typical and atypical development (i.e., visual disabilities) aged between 3 and 36 months of life. Experimental sessions will be conducted partly at home and partly in clinical centers participating in the project. Non-invasive and painless auditory and tactile stimuli will be employed, which may come from devices applied to the child's body or from sound-producing objects placed in the environment. For data analysis, video recordings will be carried out, and motion-tracking procedures will be employed. To assess the effectiveness of the training, children will be retested approximately 4 months after the end of the training, following the procedures outlined in Phases 1 and 2. These evaluative sessions will help understand if the effects of rehabilitation persist over time. Additionally, during the initial and final phases of the training, and in the follow-up, EEG techniques will be used to assess any changes in cortical activation due to the training. Number of participants:55 blind children, 55 sighted children.

The preliminary data will utilize the Power Analysis method to calculate the minimum sample size required to achieve a correct effect size for a given dimension. The data will be analyzed using both parametric and non-parametric tests, and differences between groups will be assessed with t-tests, ANOVA, TANCOVA, and linear mixed models where appropriate. An appropriate post-hoc test will be conducted if significance is found. The significance level will be considered at p\<0.05. Where necessary, parametric techniques will be replaced by non-parametric equivalents. The standard software used will include: Matlab, R, Origin, Statistica, and SPSS, recognized in the research field. For the analysis of electroencephalographic data, EEGlab and/or Fieldtrip toolboxes will be utilized. For functional magnetic resonance imaging data analysis, the FSL and/or SPM toolboxes will be employed.

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.

Primary outcomes:
measure: Perceptual responses to multisensory stimuli
timeFrame: Through study completion, an average of 5 years
measure: Stimuli velocity perception
timeFrame: Through study completion, an average of 5 years
measure: Distance stimuli perception
timeFrame: Through study completion, an average of 5 years
measure: Eye movements
timeFrame: Years 3-5
measure: Saccade Analysis
timeFrame: Years 3-5
measure: ERP evaluation and analysis
timeFrame: Through study completion, an average of 5 years
measure: Power of the cortical activity
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Unit For Visually Impaired People
Study officials:
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