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OCT and Early Cognitive Impairment in Multiple Sclerosis

Sponsor
Mansoura University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04153773
Collaborator
(none)
90
Enrollment
1
Location
13
Actual Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Aug 1, 2018
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm 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: 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

    		•
    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: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Optical coherence tomography [24-48 hours]

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

    Secondary Outcome Measures

    1. Cognitive assessment [24-48 hours]

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

    2. Expanded Disability Status Scale (EDSS) [24 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mansoura University Hospital Mansoura Dakahlia Egypt 35516

    Sponsors and Collaborators

    • Mansoura University Hospital

    Investigators

    • Principal Investigator: Esmael M Ahmed, MD, Assistant Prof of Neurology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahmed Esmael, Assistant Prof of Neurology, Mansoura University Hospital
    ClinicalTrials.gov Identifier:
    NCT04153773
    Other Study ID Numbers:
    • Mansoura University Hospital 2
    First Posted:
    Nov 6, 2019
    Last Update Posted:
    Nov 13, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Nov 13, 2019