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Completed

NCT Number: NCT04153773

OCT and Early Cognitive Impairment in Multiple Sclerosis

The aim of this study is to investigate the relationship between cognitive impairment and retinal nerve fiber layer & ganglion cell inner plexiform layer in MS.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

Cross-sectional study design, including 60 patients and 30 healthy controls. Subjects were investigated clinically, underwent retinal optical coherence tomography (OCT) and comprehensive cognitive assessments. The correlation between these modalities was evaluated by Spearman correlation.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 MS patients diagnosed according to the revised McDonald criteria 2010 were included
  • 30 healthy subjects with age and sex match control group.

Exclusion criteria

  • Medical disorder other than MS that may grossly affect cognitive functions
  • Pregnancy,
  • Previous neurological or neuropsychiatric disorders,
  • Alcohol or drug abuse,
  • MRI findings which could not be attributed to MS.
  • Severe visual disorders (> ± 6.0 dpt.)
  • History of ocular surgery, glaucoma or diabetes.

Treatment and study plan

OCT

Diagnostic Test

The degree of physical disability was assessed by using the Expanded Disability Status Scale (EDSS). The EDSS score ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

Neurocognitive functions were evaluated using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) that includes the following tests:

  • Symbol Digit Modalities Test (SDMT) that is used for assessment of information processing speed.
  • California Verbal Learning Test - 2nd edition (CVLT-II) .
  • Brief Visuospatial Memory Test-Revised (BVMT-R)

OCT assessment was performed by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans .

Each eye for every patient was assessed by measuring the thickness of RNFL and GCC, respecting presence or absence of the previous history of optic neuritis (ON).

Other names: EDSS, Cognitive assessment

Primary outcomes

  1. Optical coherence tomography

    Time frame: 24-48 hours

    OCT imaging was performed by spectral domain-optical coherence tomography to assess the retinal thickness.

Secondary outcomes

  1. Cognitive assessment

    Time frame: 24-48 hours

    Neurocognitive functions were evaluated using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)

  2. Expanded Disability Status Scale (EDSS)

    Time frame: 24 hours

    The EDSS score ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

Sponsors and collaborators

Lead sponsor

Mansoura University Hospital

Other

Registry information

Official study title

Retinal Thickness as a Potential Biomarker of Neurodegeneration and Early Cognitive Impairment in Patients With Multiple Sclerosis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2019
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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