MySpace: the Role of Vision in Representing Space

NCT06364605 | Enrolling By Invitation

• 1 other identifier: IIT_UVIP_MySpace
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

Blindness; Visual Impairment

Keywords

blindness; infants; spatial representations; EEG; child development; medical device

Outcome Measures

Primary Outcomes (7)

• Perceptual responses to multisensory stimuli

  Evaluation of the number of correct responses and reaction times (in seconds), to uni- and multisensory (audio-tactile) stimuli.

  Through study completion, an average of 5 years

• Stimuli velocity perception

  Estimation of the speed of a moving stimulus (m/s)

  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).

  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).

  Years 3-5

• Saccade Analysis

  Estimation of saccade length (pixels)

  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);

  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).

  Through study completion, an average of 5 years

Study Arms (1)

iReach Device Group

EXPERIMENTAL

Device: Rehabilitation with the iReach novel multisensory medical device

Interventions

Rehabilitation with the iReach novel multisensory medical device 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.

iReach Device Group

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Italiano di Tecnologia: lead

Study Sites (1)

Unit For Visually Impaired People

Genova, 16152, Italy

Location

Related Publications (23)

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• Gori M, Sandini G, Burr D. Development of visuo-auditory integration in space and time. Front Integr Neurosci. 2012 Sep 17;6:77. doi: 10.3389/fnint.2012.00077. eCollection 2012.

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• Cappagli G, Gori M. Auditory spatial localization: Developmental delay in children with visual impairments. Res Dev Disabil. 2016 Jun-Jul;53-54:391-8. doi: 10.1016/j.ridd.2016.02.019. Epub 2016 Mar 19.

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• Inuggi A, Pichiecchio A, Ciacchini B, Signorini S, Morelli F, Gori M. Multisystemic Increment of Cortical Thickness in Congenital Blind Children. Cereb Cortex Commun. 2020 Oct 9;1(1):tgaa071. doi: 10.1093/texcom/tgaa071. eCollection 2020.

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• Mongodi S, Ottonello G, Viggiano R, Borrelli P, Orcesi S, Pichiecchio A, Balottin U, Mojoli F, Iotti GA. Ten-year experience with standardized non-operating room anesthesia with Sevoflurane for MRI in children affected by neuropsychiatric disorders. BMC Anesthesiol. 2019 Dec 18;19(1):235. doi: 10.1186/s12871-019-0897-1.

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• Cappagli G, Cocchi E, Gori M. Auditory and proprioceptive spatial impairments in blind children and adults. Dev Sci. 2017 May;20(3). doi: 10.1111/desc.12374. Epub 2015 Nov 27.

  PMID: 26613827 RESULT

• Vercillo T, Burr D, Sandini G, Gori M. Children do not recalibrate motor-sensory temporal order after exposure to delayed sensory feedback. Dev Sci. 2015 Sep;18(5):703-12. doi: 10.1111/desc.12247. Epub 2014 Nov 28.

  PMID: 25444457 RESULT

• Tonelli A, Brayda L, Gori M. Task-dependent calibration of auditory spatial perception through environmental visual observation. Front Syst Neurosci. 2015 Jun 2;9:84. doi: 10.3389/fnsys.2015.00084. eCollection 2015.

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• Cuturi LF, Gori M. The Effect of Visual Experience on Perceived Haptic Verticality When Tilted in the Roll Plane. Front Neurosci. 2017 Dec 6;11:687. doi: 10.3389/fnins.2017.00687. eCollection 2017.

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• Campus C, Sandini G, Concetta Morrone M, Gori M. Spatial localization of sound elicits early responses from occipital visual cortex in humans. Sci Rep. 2017 Sep 5;7(1):10415. doi: 10.1038/s41598-017-09142-z.

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• Campus C, Brayda L, De Carli F, Chellali R, Fama F, Bruzzo C, Lucagrossi L, Rodriguez G. Tactile exploration of virtual objects for blind and sighted people: the role of beta 1 EEG band in sensory substitution and supramodal mental mapping. J Neurophysiol. 2012 May;107(10):2713-29. doi: 10.1152/jn.00624.2011. Epub 2012 Feb 15.

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• Delorme A, Makeig S. EEGLAB: an open source toolbox for analysis of single-trial EEG dynamics including independent component analysis. J Neurosci Methods. 2004 Mar 15;134(1):9-21. doi: 10.1016/j.jneumeth.2003.10.009.

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MeSH Terms

Conditions

Blindness; Vision Disorders

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 15, 2024
• Study Start: May 3, 2021
• Primary Completion: June 26, 2021
• Study Completion: December 31, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)