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

NCT06629155 | Not Yet Recruiting

• 1 other identifier: 24162_VisuMS
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis; Internuclear Ophthalmoplegia

Keywords

Cognitive impairment; Multiple Sclerosis; Internuclear Ophthalmoplegia; SDMT

Outcome Measures

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.

  baseline

Secondary Outcomes (2)

• Number of patients with eye movement abnormalities assessed by infrared oculography

  Baseline

• Correlation between eye movement parameters and cognitive test scores.

  Baseline

Study Arms (1)

People with multiple sclerosis

This study will include 50 people with MS (see in/exclusion criteria under "Eligibility").

Diagnostic Test: Infrared oculography

Interventions

Infrared oculography DIAGNOSTIC_TEST

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

People with multiple sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• Less than 3 months post exacerbation.
• Refusing informed consent.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Related Publications (6)

• Beier M, Gromisch ES, Hughes AJ, Alschuler KN, Madathil R, Chiaravalloti N, Foley FW. Proposed cut scores for tests of the Brief International Cognitive Assessment of Multiple Sclerosis (BICAMS). J Neurol Sci. 2017 Oct 15;381:110-116. doi: 10.1016/j.jns.2017.08.019. Epub 2017 Aug 16.

  PMID: 28991659 BACKGROUND

• Meca-Lallana V, Gascon-Gimenez F, Ginestal-Lopez RC, Higueras Y, Tellez-Lara N, Carreres-Polo J, Eichau-Madueno S, Romero-Imbroda J, Vidal-Jordana A, Perez-Miralles F. Cognitive impairment in multiple sclerosis: diagnosis and monitoring. Neurol Sci. 2021 Dec;42(12):5183-5193. doi: 10.1007/s10072-021-05165-7. Epub 2021 Apr 1.

  PMID: 33796947 BACKGROUND

• Van Schependom J, D'hooghe MB, Cleynhens K, D'hooge M, Haelewyck MC, De Keyser J, Nagels G. The Symbol Digit Modalities Test as sentinel test for cognitive impairment in multiple sclerosis. Eur J Neurol. 2014 Sep;21(9):1219-25, e71-2. doi: 10.1111/ene.12463. Epub 2014 May 22.

  PMID: 24850580 BACKGROUND

• Nij Bijvank JA, Petzold A, Balk LJ, Tan HS, Uitdehaag BMJ, Theodorou M, van Rijn LJ. A standardized protocol for quantification of saccadic eye movements: DEMoNS. PLoS One. 2018 Jul 16;13(7):e0200695. doi: 10.1371/journal.pone.0200695. eCollection 2018.

  PMID: 30011322 BACKGROUND

• Nij Bijvank JA, Hof SN, Prouskas SE, Schoonheim MM, Uitdehaag BMJ, van Rijn LJ, Petzold A. A novel eye-movement impairment in multiple sclerosis indicating widespread cortical damage. Brain. 2023 Jun 1;146(6):2476-2488. doi: 10.1093/brain/awac474.

  PMID: 36535900 BACKGROUND

• Nij Bijvank JA, van Rijn LJ, Balk LJ, Tan HS, Uitdehaag BMJ, Petzold A. Diagnosing and quantifying a common deficit in multiple sclerosis: Internuclear ophthalmoplegia. Neurology. 2019 May 14;92(20):e2299-e2308. doi: 10.1212/WNL.0000000000007499. Epub 2019 Apr 19.

  PMID: 31004067 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Ocular Motility Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Central Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Jeroen Van Schependom, PhD in Medical Sciences

CONTACT

0032 6291040; jeroen.van.schependom@vub.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 6, 2024

Record last verified: 2024-11