OCT and Early Cognitive Impairment in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153773
• Other study ID #: Mansoura University Hospital 2
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: November 2019
• Source: Mansoura University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 1, 2019
• Est. primary completion date: June 1, 2019
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Multiple Sclerosis
• Sclerosis

Intervention

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).

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (21)

Balk LJ, Cruz-Herranz A, Albrecht P, Arnow S, Gelfand JM, Tewarie P, Killestein J, Uitdehaag BM, Petzold A, Green AJ. Timing of retinal neuronal and axonal loss in MS: a longitudinal OCT study. J Neurol. 2016 Jul;263(7):1323-31. doi: 10.1007/s00415-016-81 — View Citation

Balk LJ, Sonder JM, Strijbis EM, Twisk JW, Killestein J, Uitdehaag BM, Polman CH, Petzold A. The physiological variation of the retinal nerve fiber layer thickness and macular volume in humans as assessed by spectral domain-optical coherence tomography. Invest Ophthalmol Vis Sci. 2012 Mar 9;53(3):1251-7. doi: 10.1167/iovs.11-8209. — View Citation

Benedict RHB. Brief visuospatial memory testrevised. Odessa (Fla): Psychological Assessment Resources; 1997.

Cabrera DeBuc D, Gaca-Wysocka M, Grzybowski A, Kanclerz P. Identification of Retinal Biomarkers in Alzheimer's Disease Using Optical Coherence Tomography: Recent Insights, Challenges, and Opportunities. J Clin Med. 2019 Jul 9;8(7). pii: E996. doi: 10.3390 — View Citation

Cruz-Herranz A, Balk LJ, Oberwahrenbrock T, Saidha S, Martinez-Lapiscina EH, Lagreze WA, Schuman JS, Villoslada P, Calabresi P, Balcer L, Petzold A, Green AJ, Paul F, Brandt AU, Albrecht P; IMSVISUAL consortium. The APOSTEL recommendations for reporting q — View Citation

Delis DC, Kramer JH, Kaplan E, et al. California verbal learning test - second edition. Adult version. Manual. San Antonio (TX): The Psychological Corporation; 2000.

Filippi M, Bar-Or A, Piehl F, Preziosa P, Solari A, Vukusic S, Rocca MA. Multiple sclerosis. Nat Rev Dis Primers. 2018 Nov 8;4(1):43. doi: 10.1038/s41572-018-0041-4. Review. Erratum in: Nat Rev Dis Primers. 2018 Nov 22;4(1):49. — View Citation

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Kappos L, De Stefano N, Freedman MS, Cree BA, Radue EW, Sprenger T, Sormani MP, Smith T, Häring DA, Piani Meier D, Tomic D. Inclusion of brain volume loss in a revised measure of 'no evidence of disease activity' (NEDA-4) in relapsing-remitting multiple s — View Citation

Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. — View Citation

London A, Benhar I, Schwartz M. The retina as a window to the brain-from eye research to CNS disorders. Nat Rev Neurol. 2013 Jan;9(1):44-53. doi: 10.1038/nrneurol.2012.227. Epub 2012 Nov 20. Review. — View Citation

Martinez-Lapiscina EH, Arnow S, Wilson JA, Saidha S, Preiningerova JL, Oberwahrenbrock T, Brandt AU, Pablo LE, Guerrieri S, Gonzalez I, Outteryck O, Mueller AK, Albrecht P, Chan W, Lukas S, Balk LJ, Fraser C, Frederiksen JL, Resto J, Frohman T, Cordano C, — View Citation

Méndez-Gómez JL, Pelletier A, Rougier MB, Korobelnik JF, Schweitzer C, Delyfer MN, Catheline G, Monfermé S, Dartigues JF, Delcourt C, Helmer C. Association of Retinal Nerve Fiber Layer Thickness With Brain Alterations in the Visual and Limbic Networks in — View Citation

Pérez Del Palomar A, Cegoñino J, Montolío A, Orduna E, Vilades E, Sebastián B, Pablo LE, Garcia-Martin E. Swept source optical coherence tomography to early detect multiple sclerosis disease. The use of machine learning techniques. PLoS One. 2019 May 6;14 — View Citation

Petzold A, Balcer LJ, Calabresi PA, Costello F, Frohman TC, Frohman EM, Martinez-Lapiscina EH, Green AJ, Kardon R, Outteryck O, Paul F, Schippling S, Vermersch P, Villoslada P, Balk LJ; ERN-EYE IMSVISUAL. Retinal layer segmentation in multiple sclerosis: — View Citation

Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple — View Citation

Rocca MA, Amato MP, De Stefano N, Enzinger C, Geurts JJ, Penner IK, Rovira A, Sumowski JF, Valsasina P, Filippi M; MAGNIMS Study Group. Clinical and imaging assessment of cognitive dysfunction in multiple sclerosis. Lancet Neurol. 2015 Mar;14(3):302-17. d — View Citation

Rocca MA, Battaglini M, Benedict RH, De Stefano N, Geurts JJ, Henry RG, Horsfield MA, Jenkinson M, Pagani E, Filippi M. Brain MRI atrophy quantification in MS: From methods to clinical application. Neurology. 2017 Jan 24;88(4):403-413. doi: 10.1212/WNL.00 — View Citation

Satue M, Obis J, Rodrigo MJ, Otin S, Fuertes MI, Vilades E, Gracia H, Ara JR, Alarcia R, Polo V, Larrosa JM, Pablo LE, Garcia-Martin E. Optical Coherence Tomography as a Biomarker for Diagnosis, Progression, and Prognosis of Neurodegenerative Diseases. J — View Citation

Serbecic N, Aboul-Enein F, Beutelspacher SC, Vass C, Kristoferitsch W, Lassmann H, Reitner A, Schmidt-Erfurth U. High resolution spectral domain optical coherence tomography (SD-OCT) in multiple sclerosis: the first follow up study over two years. PLoS On — View Citation

Smith A. Symbol digit modalities test: manual. Western Psychological Corporation. Los Angeles (CA): Western Psychological Services; 2002.

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optical coherence tomography	OCT imaging was performed by spectral domain-optical coherence tomography to assess the retinal thickness.	24-48 hours
Secondary	Cognitive assessment	Neurocognitive functions were evaluated using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)	24-48 hours
Secondary	Expanded Disability Status Scale (EDSS)	The EDSS score ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.	24 hours