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

Sponsor

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

Overall Status

Active, not recruiting

CT.gov ID

NCT04937725

Collaborator

Hospital Clínico Universitario de Valladolid (Other), Hospital del Río Hortega (Other)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Injury Brain Eye Abnormalities Multiple Sclerosis Parkinson Disease Ataxia, Cerebellar	Diagnostic Test: eye tracking

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

75 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Reading Problems Associated With Central Nervous System Pathologies

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Sep 21, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients without neurological pathologies Patients with no history of neurological diseases	Diagnostic Test: eye tracking Eye tracker will be used to evaluate study parameters
Patients with neurological pathologies	Diagnostic Test: eye tracking Eye tracker will be used to evaluate study parameters

Arm

Intervention/Treatment

Patients without neurological pathologies

Patients with no history of neurological diseases

Diagnostic Test: eye tracking

Eye tracker will be used to evaluate study parameters

Patients with neurological pathologies

Diagnostic Test: eye tracking

Eye tracker will be used to evaluate study parameters

Outcome Measures

Primary Outcome Measures

Reading performance [24 Hours]
International Reading Speed Texts (IReST)

Secondary Outcome Measures

Reading performance [24 Hours]
DEM (Developmental Eye Movement).ocular (DEM)

Other Outcome Measures

Eye tracking [24 Hours]
Eye-tracking test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IOBA - Universidad de Valladolid	Valladolid		Spain	47011

Sponsors and Collaborators

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Hospital Clínico Universitario de Valladolid
Hospital del Río Hortega