OCT and Early Cognitive Impairment in Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT04153773
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 60 MS patients diagnosed according to the revised McDonald criteria 2010 were included
- 30 healthy subjects with age and sex match control group.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Optical coherence tomography 24-48 hours OCT imaging was performed by spectral domain-optical coherence tomography to assess the retinal thickness.
- Secondary Outcome Measures
Name Time Method Cognitive assessment 24-48 hours Neurocognitive functions were evaluated using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
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.
Trial Locations
- Locations (1)
Mansoura University Hospital
🇪🇬Mansoura, Dakahlia, Egypt
Mansoura University Hospital🇪🇬Mansoura, Dakahlia, Egypt