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

NCT04937725 | Completed

• 1 other identifier: PI21-2247 TFM
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

eye tracking

Outcome Measures

Primary Outcomes (1)

• Reading performance

  International Reading Speed Texts (IReST)

  24 Hours

Secondary Outcomes (1)

• Reading performance

  24 Hours

Other Outcomes (1)

• Eye tracking

  24 Hours

Study Arms (2)

Patients without neurological pathologies

Patients with no history of neurological diseases

Diagnostic Test: eye tracking

Patients with neurological pathologies

Diagnostic Test: eye tracking

Interventions

eye tracking DIAGNOSTIC_TEST

Eye tracker will be used to evaluate study parameters

Patients with neurological pathologies; Patients without neurological pathologies

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

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

Study Sites (1)

IOBA - Universidad de Valladolid

Valladolid, 47011, Spain

Location

MeSH Terms

Conditions

Brain Injuries; Eye Abnormalities; Multiple Sclerosis; Parkinson Disease; Cerebellar Ataxia

Interventions

Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Eye Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cerebellar Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: June 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 30, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

ES (1)