Reading Problems Associated With Central Nervous System (CNS) Pathologies.
NCT ID: NCT04937725
Last Updated: 2023-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2021-06-01
2022-11-30
Brief Summary
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The exploration is focused on the oculomotor system in patients with CNS diseases, even without involvement of the primary visual pathway, and reveals more involvement than the one obtained by a simple ophthalmological examination.
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Detailed Description
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Neuropsychological function Clock Test- Clock Drawing, whose score corresponds to a scale of 1 to 6, from perfect organization to severe disorder respectively, with a cognitive deficit being a result greater than 3. This test is used to detect signs of heminegligence in addition to the Line Bisection Test. It will consider the displacement of the central mark to the right side as a positive sign.
Mini-Cognitive Exam, whose cut-off score corresponds to 23 out of the 30 total, equal to or less than this figure, would indicate the presence of a cognitive deficit.
Far and near Best corrected visual acuity Primary gaze position Cover test (far and near) Extrinsic ocular motility Nystagmus presence Intrinsic ocular motility Biomicroscopy of the anterior pole Computerized visual field 30-2 Intraocular pressure Ocular fundus examination Records with Tobii Pro Nano Hardware Package eye-tracking system and Tobii Pro Lab - Full Edition software.
Reading performance assessment: International Reading Speed Texts (IReST) Attentional questionnaire based on the IReST, two simple answer questions (one word) will be formulated for each text, at the end of the reading to check the reading comprehension of the patient Evaluation of the speed and quality of horizontal and vertical reading: Test DEM (Developmental Eye Movement).
Eye-tracking test: with an animation of a moving circle.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with neurological pathologies
eye tracking
Eye tracker will be used to evaluate study parameters
Patients without neurological pathologies
Patients with no history of neurological diseases
eye tracking
Eye tracker will be used to evaluate study parameters
Interventions
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eye tracking
Eye tracker will be used to evaluate study parameters
Eligibility Criteria
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Inclusion Criteria
* Clinical radiological neurological stability in acute CNS diseases (≥ 3 months after ACD).
* Best distant binocular visual acuity, equal or greater than 0.5 (Decimal Scale). Best close binocular visual acuity, equal or greater than 20/40.Glasses or soft contact lenses users.
Exclusion Criteria
* Presence of visual agnosia: Poppelreuter-Ghent © test.
* Presence of cognitive deficit: mini mental state examination (MMSE), with sufficient residual hearing capacity.
* Medical history, or presence after ophthalmic examination of: maculopathy, advanced cataracts, ophthalmological diseases affecting central visual acuity or macular fixation.
* Healthy control subjects should have normal monocular perimetry using standard Swedish interactive threshold algorithm (SITA) Central 30-2 Humphrey® Perimeter Test .
18 Years
80 Years
ALL
Yes
Sponsors
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Hospital Clínico Universitario de Valladolid
OTHER
Hospital del Rio Hortega
OTHER
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
OTHER
Responsible Party
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Locations
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IOBA - Universidad de Valladolid
Valladolid, , Spain
Countries
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Other Identifiers
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PI21-2247 TFM
Identifier Type: -
Identifier Source: org_study_id
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