Studying Eye Movement Deficits and Cognitive Impairment in Patients with Multiple Sclerosis Using Infrared Eye Tracking and Cognitive Tests

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel

About this trial

The goal of this observational study is to study the relationship between cognitive problems and problems in eye movements in Multiple Sclerosis (MS).

The main questions it aims to answer are:

* What is the correlation between eye movement parameters (VDI AUC and VDI Pv/Am, left and right) and SDMT scores in patients with MS? * What is the number of patients with VDI AUC\>1.174 and/or VDI Pv/Am\>1.180 assessed by infrared oculography during prosaccades at 15 degrees left or right? * What is the correlation between eye movement parameters (VDI AUC and VDI Pv/Am, left and right) and cognitive test scores in patients with MS?

Participants will perform specific cognitive tests and eye movements will be measured through infrared oculography.

The primary hypothesis for the study is: participants who exceed the treshold (VDI AUC\>1.174 and/or VDI Pv/Am\>1.180, left or right) will perform worse on cognitive tests compared to those who don't.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with clinically definite multiple sclerosis according to the 2017 McDonald criteria

At least 18 years old

Combined vision with optimal correction > 0,6 on Snellen Visual Acuity Test.

Providing informed consent.

Disqualifiers

Major medical or psychiatric pathology that potentially affects cognitive functioning.

A score higher than 63 on the Fatigue Scale for Motor and Cognitive Functions is categorized as severe fatigue

Start or switch in immunomodulatory treatment within three months before inclusion.

Less than 3 months post exacerbation.

Trial population

MS patients recruited from the neurology department of UZ Brussels and NMSC Melsbroek in Belgium

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Infrared oculography

    Diagnostic test

    Eye movements will be captured through infrared oculography and processed via in-house algorithms.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: People with multiple sclerosis1 intervention

Trial outcomes

Primary outcomes

1

Correlation between eye movement parameters and SDMT.

Correlation between eye movement parameters (VDI AUC and VDI Pv/Am, left and right) and SDMT scores in patients with MS.

Time frame
baseline

Secondary outcomes

1

Number of patients with eye movement abnormalities assessed by infrared oculography

The number of patients with VDI AUC\>1.174 and/or VDI Pv/Am\>1.180 assessed by infrared oculography during prosaccades at 15 degrees left or right.

Time frame
Baseline
2

Correlation between eye movement parameters and cognitive test scores.

The cognitive tests used to asses this correlation include the following: the PASAT (Paced Auditory Serial Addition Task), the CVLT-II (California Verbal Learning Test-II) and the BVMT-R (Brief Visuospatial Memory Test Revised). The correlation between eye movement parameters parameters (VDI Pv/Am and VDI AUC, left and right), and cognitive test scores will be analyzed through Spearman correlation analysis.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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