- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06088797
Exploration of the Role of Vision on Spatial Cognition (SpatioCog)
Study Overview
Status
Conditions
Intervention / Treatment
- 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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Laure PISELLA, Dr
- Phone Number: 04 72 91 34 12
- Email: laure.pisella@inserm.fr
Study Contact Backup
- Name: Hind DRISSI
- Email: hind.drissi@inserm.fr
Study Locations
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-
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Lyon, France
- Recruiting
- Equipe Trajectoire du CRNL : INSERM U1028, CNRS UMR 5292
-
Contact:
- Hind DRISSI
- Email: hind.drissi@inserm.fr
-
Contact:
- Laure PISSELA, DR
- Phone Number: 04 72 91 34 12
- Email: laure.pisella@inserm.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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°).
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
healthy subjects
First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes
|
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. 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.
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.
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 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.
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
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.
|
|
blind
First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes
|
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.
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.
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 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.
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
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.
|
|
low visual acuity
First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes
|
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. 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.
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.
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 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.
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
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.
|
|
reduced visual field
First time :WISC V 40 minutes Second time :Completion of the 4 experimental tasks 105 minutes
|
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. 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.
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.
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 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.
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
through study completion, an average of 2 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laure PISELLA, Dr, Equipe Trajectoire du CRNL : INSERM U1028, CNRS UMR 5292)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL23_0361
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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