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OCT and Early Cognitive Impairment in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT04153773
Recruitment Status : Completed
First Posted : November 6, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Esmael, Mansoura University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Multiple Sclerosis Diagnostic Test: OCT

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.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Retinal Thickness as a Potential Biomarker of Neurodegeneration and Early Cognitive Impairment in Patients With Multiple Sclerosis
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153773


Locations
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Egypt
Mansoura University Hospital
Mansoura, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University Hospital
Investigators
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Principal Investigator: Esmael M Ahmed, MD Assistant Prof of Neurology

Publications of Results:
Smith A. Symbol digit modalities test: manual. Western Psychological Corporation. Los Angeles (CA): Western Psychological Services; 2002.
Delis DC, Kramer JH, Kaplan E, et al. California verbal learning test - second edition. Adult version. Manual. San Antonio (TX): The Psychological Corporation; 2000.
Benedict RHB. Brief visuospatial memory testrevised. Odessa (Fla): Psychological Assessment Resources; 1997.

Other Publications:
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Responsible Party: Ahmed Esmael, Assistant Prof of Neurology, Mansoura University Hospital
ClinicalTrials.gov Identifier: NCT04153773     History of Changes
Other Study ID Numbers: Mansoura University Hospital 2
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Cognitive Dysfunction
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders