Skip to content

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

Reading Problems Associated With Central Nervous System Pathologies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04937725
Enrollment
75
Registered
2021-06-24
Start date
2021-06-01
Completion date
2022-11-30
Last updated
2023-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury Brain, Eye Abnormalities, Multiple Sclerosis, Parkinson Disease, Ataxia, Cerebellar

Keywords

eye tracking

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.

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.

Interventions

DIAGNOSTIC_TESTeye tracking

Eye tracker will be used to evaluate study parameters

Sponsors

Hospital Clínico Universitario de Valladolid
CollaboratorOTHER
Hospital del Rio Hortega
CollaboratorOTHER
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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 .

Design outcomes

Primary

MeasureTime frameDescription
Reading performance24 HoursInternational Reading Speed Texts (IReST)

Secondary

MeasureTime frameDescription
Reading performance24 HoursDEM (Developmental Eye Movement).ocular (DEM)

Other

MeasureTime frameDescription
Eye tracking24 HoursEye-tracking test

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026