Visual DeficienciesSpatioCogNCT06088797
Exploration of the Role of Vision on Spatial Cognition
An observational study of Visual Deficiencies, run by Hospices Civils de Lyon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Deficiencies
- What is being tested?
- METRIC COMPARISON Tasks : Tactile PVSE test, METRIC COMPARISON Tasks : Classic PVSE test and Mental imagery task
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2023to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: participant with Visual Deficiencies monitored in the " Centre Technique Régional pour la Déficience Visuelle" or at the " école spécialisée pour déficients visuels "
Who may be able to join
- 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:
Show all 9Show fewer
- with congenital blindness
- or low visual acuity (between 1/10 and 3/10)
- or with visual field peripheral shrinkage (angle <20°).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Hind DRISSI contact
France1 site, 1 recruiting
- Recruiting
Equipe Trajectoire du CRNL : INSERM U1028, CNRS UMR 5292
Lyon
Laure PISSELA, DR, 04 72 91 34 12, laure.pisella@inserm.fr
Hind DRISSI, hind.drissi@inserm.fr
About this study
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.
- Conditions
- Visual Deficiencies
- Being tested
- METRIC COMPARISON Tasks : Tactile PVSE test, METRIC COMPARISON Tasks : Classic PVSE test, Mental imagery task, Proprioceptive spatial representation tasks, Tasks assessing number sense based on relative positions or lengths
- Keywords
- spatial cognition, arithmetic, visual deficiency, blind
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
METRIC COMPARISON Tasks : Tactile PVSE testOther
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.
METRIC COMPARISON Tasks : Classic PVSE testOther
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.
Mental imagery taskOther
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.
Proprioceptive spatial representation tasksOther
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
Tasks assessing number sense based on relative positions or lengthsOther
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.
WISC V Similarity and Span TestOther
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
WISC V Arithmetic subtestOther
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.
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes Receives: Other: METRIC COMPARISON Tasks : Tactile PVSE test; Other: METRIC COMPARISON Tasks : Classic PVSE test; Other: Mental imagery task; Other: Proprioceptive spatial representation tasks; Other: Tasks assessing number sense based on relative positions or lengths; Other: WISC V Similarity and Span Test; Other: WISC V Arithmetic subtest | |
| blind | First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes Receives: Other: METRIC COMPARISON Tasks : Tactile PVSE test; Other: Mental imagery task; Other: Proprioceptive spatial representation tasks; Other: Tasks assessing number sense based on relative positions or lengths; Other: WISC V Similarity and Span Test; Other: WISC V Arithmetic subtest | |
| low visual acuity | First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes Receives: Other: METRIC COMPARISON Tasks : Tactile PVSE test; Other: METRIC COMPARISON Tasks : Classic PVSE test; Other: Mental imagery task; Other: Proprioceptive spatial representation tasks; Other: Tasks assessing number sense based on relative positions or lengths; Other: WISC V Similarity and Span Test; Other: WISC V Arithmetic subtest | |
| reduced visual field | First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes Receives: Other: METRIC COMPARISON Tasks : Tactile PVSE test; Other: METRIC COMPARISON Tasks : Classic PVSE test; Other: Mental imagery task; Other: Proprioceptive spatial representation tasks; Other: Tasks assessing number sense based on relative positions or lengths; Other: WISC V Similarity and Span Test; Other: WISC V Arithmetic subtest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start20 Oct 2023
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual DeficienciesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure PISELLA, Dr, Principal investigator, Equipe Trajectoire du CRNL : INSERM U1028, CNRS UMR 5292)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088797
- Sponsor's protocol ID
- 69HCL23_0361
- Acronym
- SpatioCog
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Role of Vision on Spatial Cognition
- ClinicalTrials.gov ID
- NCT06088797
- Acronym / sponsor ID
- SpatioCog / 69HCL23_0361
- Conditions
- Visual Deficiencies
- Keywords
- spatial cognition, arithmetic, visual deficiency, blind
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | – | Other: METRIC COMPARISON Tasks : Tactile PVSE test, Other: METRIC COMPARISON Tasks : Classic PVSE test, Other: Mental imagery task, Other: Proprioceptive spatial representation tasks, Other: Tasks assessing number sense based on relative positions or lengths, Other: WISC V Similarity and Span Test, Other: WISC V Arithmetic subtestFirst time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes |
| blind | – | Other: METRIC COMPARISON Tasks : Tactile PVSE test, Other: Mental imagery task, Other: Proprioceptive spatial representation tasks, Other: Tasks assessing number sense based on relative positions or lengths, Other: WISC V Similarity and Span Test, Other: WISC V Arithmetic subtestFirst time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes |
| low visual acuity | – | Other: METRIC COMPARISON Tasks : Tactile PVSE test, Other: METRIC COMPARISON Tasks : Classic PVSE test, Other: Mental imagery task, Other: Proprioceptive spatial representation tasks, Other: Tasks assessing number sense based on relative positions or lengths, Other: WISC V Similarity and Span Test, Other: WISC V Arithmetic subtestFirst time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes |
| reduced visual field | – | Other: METRIC COMPARISON Tasks : Tactile PVSE test, Other: METRIC COMPARISON Tasks : Classic PVSE test, Other: Mental imagery task, Other: Proprioceptive spatial representation tasks, Other: Tasks assessing number sense based on relative positions or lengths, Other: WISC V Similarity and Span Test, Other: WISC V Arithmetic subtestFirst time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- participant with Visual Deficiencies monitored in the " Centre Technique Régional pour la Déficience Visuelle" or at the " école spécialisée pour déficients visuels "
Key inclusion criteria (9 listed)
- Aged 12 to 25
- Participant not opposed to the research and parents do not oppose participation in the protocol for minors
- with typical visual development with correction if needed
- with congenital blindness
- or low visual acuity (between 1/10 and 3/10)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| METRIC COMPARISON Tasks : Tactile PVSE testTactile 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. | Other | blind, healthy subjects, low visual acuity, reduced visual field |
| METRIC COMPARISON Tasks : Classic PVSE testClassic 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. | Other | healthy subjects, low visual acuity, reduced visual field |
| Mental imagery taskThis 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. | Other | blind, healthy subjects, low visual acuity, reduced visual field |
| Proprioceptive spatial representation tasks16 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 | Other | blind, healthy subjects, low visual acuity, reduced visual field |
| Tasks assessing number sense based on relative positions or lengthsPointing 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. | Other | blind, healthy subjects, low visual acuity, reduced visual field |
| WISC V Similarity and Span TestThe 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 | Other | blind, healthy subjects, low visual acuity, reduced visual field |
| WISC V Arithmetic subtestThe 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. | Other | blind, healthy subjects, low visual acuity, reduced visual field |
Primary outcome
percentage of correct responses
Time frame: through study completion, an average of 2 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hind DRISSI contact
Laure PISELLA, Dr principal investigator
Equipe Trajectoire du CRNL : INSERM U1028, CNRS UMR 5292)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Deficiencies, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laure PISELLA, Dr (04 72 91 34 12, laure.pisella@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of correct responses (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.