Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364605
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-15
First Post:
2024-03-26
Brief Title:
MySpace the Role of Vision in Representing Space
Sponsor:
Istituto Italiano di Tecnologia
Organization:
Istituto Italiano di Tecnologia
Study Overview
Official Title:
MySpace the Role of Vision on Perceptual Space Representation
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 audiotactile 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 participants 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 ie 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 childs 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 participants55 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 p005 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 andor Fieldtrip toolboxes will be utilized For functional magnetic resonance imaging data analysis the FSL andor SPM toolboxes will be employed
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 participants 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 ie 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 childs 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 participants55 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 p005 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 andor Fieldtrip toolboxes will be utilized For functional magnetic resonance imaging data analysis the FSL andor SPM toolboxes will be employed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None