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

Multiple Sclerosis Clinical Trial

Official title:

Reading Problems Associated With Central Nervous System Pathologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04937725
• Other study ID #: PI21-2247 TFM
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 30, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Ataxia
• Ataxia, Cerebellar
• Cerebellar Ataxia
• Eye Abnormalities
• Multiple Sclerosis
• Parkinson Disease

Intervention

Diagnostic Test:
• eye tracking
Eye tracker will be used to evaluate study parameters

Locations

Country	Name	City	State
Spain	IOBA - Universidad de Valladolid	Valladolid

Sponsors (3)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eye tracking	Eye-tracking test	24 Hours
Primary	Reading performance	International Reading Speed Texts (IReST)	24 Hours
Secondary	Reading performance	DEM (Developmental Eye Movement).ocular (DEM)	24 Hours