OCT and Early Cognitive Impairment in Multiple Sclerosis

November 9, 2019 updated by: Ahmed Esmael, Mansoura University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Mansoura University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This was a cross-sectional study that was conducted in the Neurology Department of Mansoura University Faculty of Medicine, Egypt. 60 patients with MS were recruited from the period of Aug 2018 to September 2019.

Participants 60 MS patients diagnosed according to the revised McDonald criteria 2010 were included . Both sexes aged 20-45 year were included.

Age and sex matched the healthy control (HC) group which consisted of 30 subjects without any neurological or psychiatric disease and who were not related (within the first or second degree of consanguinity) to a patient with MS.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
60 Patient
Diagnostic test: OCT

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:

  1. Symbol Digit Modalities Test (SDMT) that is used for assessment of information processing speed.
  2. California Verbal Learning Test - 2nd edition (CVLT-II) .
  3. 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
Group 2
30 Control subject
Diagnostic test: OCT

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:

  1. Symbol Digit Modalities Test (SDMT) that is used for assessment of information processing speed.
  2. California Verbal Learning Test - 2nd edition (CVLT-II) .
  3. 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optical coherence tomography
Time Frame: 24-48 hours
OCT imaging was performed by spectral domain-optical coherence tomography to assess the retinal thickness.
24-48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive assessment
Time Frame: 24-48 hours
Neurocognitive functions were evaluated using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
24-48 hours
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

November 2, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 9, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mansoura University Hospital 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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