An interventional study of Rehabilitation with the iReach novel multisensory medical device in Blindness and Visual Impairment, sponsored by Istituto Italiano di Tecnologia. Enrolling by invitation at 1 site in Italy. Open to participants aged 3 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by Istituto Italiano di Tecnologia · Not applicable, Interventional, and Basic science
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.
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:
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.
144 studies on the registry are indexed under Blindness; 33 are open to participants now.
This study's planned enrollment of 720 is above the median of 37 across 101 interventional studies indexed under Blindness.
Browse Blindness studies →Istituto Italiano di Tecnologia is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Rehabilitation with the iReach novel multisensory medical device
From the results of Phases 1,2 and 3, in Phase 4 a medical device for spatial and sensorimotor rehabilitation in infants aged 3 to 36 months will be tested and developed.
Perceptual responses to multisensory stimuli
Evaluation of the number of correct responses and reaction times (in seconds), to uni- and multisensory (audio-tactile) stimuli.
Time frame: Through study completion, an average of 5 years
Stimuli velocity perception
Estimation of the speed of a moving stimulus (m/s)
Time frame: Through study completion, an average of 5 years
Distance stimuli perception
Estimation of the the distance traveled by a moving stimulus (m), along with an estimate of the error made in identifying the endpoint of the stimulus by the participant (m).
Time frame: Through study completion, an average of 5 years
Eye movements
Eye movements are evaluated in terms of fixation duration (s) and time to first fixation (TTFF) (ms).
Time frame: Years 3-5
Saccade Analysis
Estimation of saccade length (pixels)
Time frame: Years 3-5
ERP evaluation and analysis
Evaluation of the Event-Related-Potentials (ERPs) in terms of the number of spikes and their Amplitude (μV);
Time frame: Through study completion, an average of 5 years
Power of the cortical activity
Evaluation of power expressed by the alpha band (8-12 Hz) of the EEG recorded in the occipital area (dB).
Time frame: Through study completion, an average of 5 years
Plan to share: Yes
Ran from May 2021 to primary completion in Jun 2021, 1 month.
Of 36 interventional studies with no phase under Blindness, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 19. This study's 1 month is below that.
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Istituto Italiano di Tecnologia