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

Reading Problems Associated With Central Nervous System Pathologies

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Eye Abnormalities; Parkinson Disease; Ataxia, Cerebellar; Injury Brain
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47011
    • IOBA - Universidad de Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Normal population (no pathology) and people with neurological pathologies such as multiple sclerosis, Parkinson, tumours, or stroke, cerebellum ataxia and other miscellaneous neurological disorders.

Description

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 .

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading performance	International Reading Speed Texts (IReST)	24 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading performance	DEM (Developmental Eye Movement).ocular (DEM)	24 Hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye tracking	Eye-tracking test	24 Hours

Collaborators and Investigators

• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Collaborators: Hospital del Rio Hortega; Hospital Clínico Universitario de Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: eye tracking
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Neurologic Manifestations; Congenital Abnormalities; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Cerebellar Diseases; Multiple Sclerosis; Parkinson Disease; Ataxia; Cerebellar Ataxia; Eye Abnormalities
• Other Study ID Numbers: PI21-2247 TFM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No