OCT and Early Cognitive Impairment in Multiple Sclerosis
NCT ID: NCT04153773
Last Updated: 2019-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2018-08-01
2019-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Group 1
60 Patient
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).
Group 2
30 Control subject
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 30 healthy subjects with age and sex match control group.
Exclusion Criteria
* 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.
20 Years
45 Years
ALL
No
Sponsors
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Mansoura University Hospital
OTHER
Responsible Party
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Ahmed Esmael
Assistant Prof of Neurology
Principal Investigators
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Esmael M Ahmed, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Prof of Neurology
Locations
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Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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References
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Other Identifiers
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Mansoura University Hospital 2
Identifier Type: -
Identifier Source: org_study_id
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