Reading Problems Associated With Central Nervous System (CNS) Pathologies.

NCT ID: NCT04937725

Last Updated: 2023-02-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-11-30

Brief Summary

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This project aims to analyse eye movements, their alterations and influence in reading performance in patients with acquired CNS diseases and compare them with people of the same age, without neurological or ocular pathology and with normal reading speed and pattern.

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.

Detailed Description

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The following protocol will be applied:

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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Injury Brain Eye Abnormalities Multiple Sclerosis Parkinson Disease Ataxia, Cerebellar

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with neurological pathologies

eye tracking

Intervention Type DIAGNOSTIC_TEST

Eye tracker will be used to evaluate study parameters

Patients without neurological pathologies

Patients with no history of neurological diseases

eye tracking

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients and normal volunteers with ages between 18 and 80 years old.
* 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 heminegligence evaluated with clock drawing test and line bisection test.
* 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 .
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role collaborator

Hospital del Rio Hortega

OTHER

Sponsor Role collaborator

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IOBA - Universidad de Valladolid

Valladolid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PI21-2247 TFM

Identifier Type: -

Identifier Source: org_study_id

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