NCT06088797

Brief Summary

Atypical developpement of spatial cognition has been shown in congenital bindness with some consequences on mathematic learning (Cattaneo et al., 2010) as well as on the mental representation of spatial maps (Thinus-Blanc \& Gaunet, 1997). This raises the issue of the role of vision in spatial abilities underlying mathematics and locomotion. These difficulties could also be found in case of partial visual deficiency, like very low visual acuity or large peripheral shrinkage of the visual field.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

October 5, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

spatial cognitionarithmeticvisual deficiencyblind

Outcome Measures

Primary Outcomes (1)

  • percentage of correct responses

    The experimental tasks assess allocentric spatial representations in different modalities with correct responses to spatial vs non spatial questions for the Elementary Spatial Perception test and the mental imagery test.

    through study completion, an average of 2 year

Study Arms (4)

healthy subjects

First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes

Other: METRIC COMPARISON Tasks : Tactile PVSE testOther: METRIC COMPARISON Tasks : Classic PVSE testOther: Mental imagery taskOther: Proprioceptive spatial representation tasksOther: Tasks assessing number sense based on relative positions or lengthsOther: WISC V Similarity and Span TestOther: WISC V Arithmetic subtest

blind

First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes

Other: METRIC COMPARISON Tasks : Tactile PVSE testOther: Mental imagery taskOther: Proprioceptive spatial representation tasksOther: Tasks assessing number sense based on relative positions or lengthsOther: WISC V Similarity and Span TestOther: WISC V Arithmetic subtest

low visual acuity

First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes

Other: METRIC COMPARISON Tasks : Tactile PVSE testOther: METRIC COMPARISON Tasks : Classic PVSE testOther: Mental imagery taskOther: Proprioceptive spatial representation tasksOther: Tasks assessing number sense based on relative positions or lengthsOther: WISC V Similarity and Span TestOther: WISC V Arithmetic subtest

reduced visual field

First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes

Other: METRIC COMPARISON Tasks : Tactile PVSE testOther: METRIC COMPARISON Tasks : Classic PVSE testOther: Mental imagery taskOther: Proprioceptive spatial representation tasksOther: Tasks assessing number sense based on relative positions or lengthsOther: WISC V Similarity and Span TestOther: WISC V Arithmetic subtest

Interventions

Tactile PVSE test The tests are presented in 6 independent booklets, each of which tests a distinct skill: comparison of lengths, comparison of sizes, comparison of obliques, perception of environments, comparison of relative positions in relation to a frame and comparison of relative positions with distractors. The assessment sheet presented in a table with the expected answers will allow you to note whether the answers are correct (rating 1) or not (rating 0). A total of the correct answers from all the sub-tests will give a total score.

blindhealthy subjectslow visual acuityreduced visual field

Classic PVSE test Use of the standardized PVSE test printed on thick white paper in 6 separate booklets each containing a subtest (length, size, oblique, middle, relative position and relative position with distractor) The assessment sheet presented in a table with the expected answers will allow you to note whether the answers are correct (rating 1) or not (rating 0). A total of the correct answers from all the sub-tests will give a total score.

healthy subjectslow visual acuityreduced visual field

This involves answering questions concerning the position or identity of 2 or 3 objects on the basis of the mental representation of a grid by auditory guidance. Each grid must be constructed mentally with the verbal description of the path and the objects encountered.

blindhealthy subjectslow visual acuityreduced visual field

16 configurations of 3 objects with direct or indirect passive exploration of their relative positions. Each grid is presented 3 times with the following 3 questions to which the subject answers yes or no by forced choice a single measure of the number of correct answers which will be the sum of the correct answers obtained to each of the 3 questions in the direct vs indirect condition

blindhealthy subjectslow visual acuityreduced visual field

Pointing exercises on a digital line of 50 cm paper tape: the participant points with his finger to a position on the tape, according to the verbal request of the experimenter Measures the intermanual gap during requests for evaluation of 5 times the wand, subtracting the length of a wand, then dividing this length by 2.

blindhealthy subjectslow visual acuityreduced visual field

The Wechsler Intelligence Scale for Children - Fifth Edition, Australian Standard (WISC-V) is an individually administered and comprehensive clinical instrument used to assess the general thinking and reasoning skills of children aged six years to 16 years. Test results include a Full-Scale Intelligence Quotient (IQ) score as well as age-equivalent rankings and scores for Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory and Processing Speed composites

blindhealthy subjectslow visual acuityreduced visual field

The WISC-V is an individually administered, comprehensive clinical instrument for assessing the intelligence of children. The primary and secondary subtests are on a scaled score metric with a mean of 10 and a standard deviation (SD) of 3. These subtest scores range from 1 to19, with scores between 8 and 12 typically considered average.

blindhealthy subjectslow visual acuityreduced visual field

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

participant with Visual Deficiencies monitored in the " Centre Technique Régional pour la Déficience Visuelle" or at the " école spécialisée pour déficients visuels "

You may qualify if:

  • For all :
  • Aged 12 to 25
  • Participant not opposed to the research and parents do not oppose participation in the protocol for minors
  • For healthy volunteers (normal sighted):
  • \- with typical visual development with correction if needed
  • For participant with Visual Deficiencies:
  • with congenital blindness
  • or low visual acuity (between 1/10 and 3/10)
  • or with visual field peripheral shrinkage (angle \<20°).

You may not qualify if:

  • General knowledge and working memory skills with a standard score of less than 4
  • neurological medical history
  • Person deprived of liberty by judicial or administrative decision
  • Person subject to a legal protection measure (tutorship, curatorship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Equipe Trajectoire du CRNL : INSERM U1028, CNRS UMR 5292

Lyon, France

RECRUITING

Study Officials

  • Laure PISELLA, Dr

    Equipe Trajectoire du CRNL : INSERM U1028, CNRS UMR 5292)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hind DRISSI

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 18, 2023

Study Start

October 20, 2023

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations