OCT and Early Cognitive Impairment in Multiple Sclerosis

An observational study of Multiple Sclerosis, run by Mansoura University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 20 to 45 years
Conditions the study is for: Multiple Sclerosis
What is being tested?: OCT
How many people: 90 participants
Where: 1 siteEgypt
Study dates: 1 Aug 2018to 1 Sep 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
All sexes
Adult

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.

Who may be able to join

60 MS patients diagnosed according to the revised McDonald criteria 2010 were included
30 healthy subjects with age and sex match control group.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516

Other trials in Egypt

About this study

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

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.

Read the 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.

Conditions: Multiple Sclerosis
Being tested: OCT
Medical subject headings: Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OCTDiagnostic test
Also called EDSS, Cognitive assessment
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).

Study groups in NCT04153773
Study group	Role	What they receive
Group 1		60 Patient Receives: Diagnostic Test: OCT
Group 2		30 Control subject Receives: Diagnostic Test: OCT

What is being measured

The primary outcome is the main question the study is designed to answer.

Optical coherence tomography
OCT imaging was performed by spectral domain-optical coherence tomography to assess the retinal thickness.
Measured: 24-48 hours

Secondary outcomes (2)

Cognitive assessment
Neurocognitive functions were evaluated using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Measured: 24-48 hours
Expanded Disability Status Scale (EDSS)
The EDSS score ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20181 Sep 2019

First posted6 Nov 2019
Study start1 Aug 2018
Primary completion1 Jun 2019
Study completion1 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Multiple SclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04153773
Sponsor's protocol ID: Mansoura University Hospital 2
Status last verified: Nov 2019
First submitted: 2 Nov 2019
Last updated: 13 Nov 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 22266522
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.
PubMed 30410033
Kalb R, Beier M, Benedict RH, Charvet L, Costello K, Feinstein A, Gingold J, Goverover Y, Halper J, Harris C, Kostich L, Krupp L, Lathi E, LaRocca N, Thrower B, DeLuca J. Recommendations for cognitive screening and management in multiple sclerosis care. Mult Scler. 2018 Nov;24(13):1665-1680. doi: 10.1177/1352458518803785. Epub 2018 Oct 10.
PubMed 30303036
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. doi: 10.1016/S1474-4422(14)70250-9. Epub 2015 Feb 4.
PubMed 25662900
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.0000000000003542. Epub 2016 Dec 16.
PubMed 27986875
Kappos L, De Stefano N, Freedman MS, Cree BA, Radue EW, Sprenger T, Sormani MP, Smith T, Haring 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 sclerosis. Mult Scler. 2016 Sep;22(10):1297-305. doi: 10.1177/1352458515616701. Epub 2015 Nov 19.
PubMed 26585439
Perez Del Palomar A, Cegonino J, Montolio A, Orduna E, Vilades E, Sebastian 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(5):e0216410. doi: 10.1371/journal.pone.0216410. eCollection 2019.
PubMed 31059539
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, Zubizarreta I, Andorra M, Sanchez-Dalmau B, Saiz A, Bermel R, Klistorner A, Petzold A, Schippling S, Costello F, Aktas O, Vermersch P, Oreja-Guevara C, Comi G, Leocani L, Garcia-Martin E, Paul F, Havrdova E, Frohman E, Balcer LJ, Green AJ, Calabresi PA, Villoslada P; IMSVISUAL consortium. Retinal thickness measured with optical coherence tomography and risk of disability worsening in multiple sclerosis: a cohort study. Lancet Neurol. 2016 May;15(6):574-84. doi: 10.1016/S1474-4422(16)00068-5. Epub 2016 Mar 18.
PubMed 27011339
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.
PubMed 23165340
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 Ophthalmol. 2016;2016:8503859. doi: 10.1155/2016/8503859. Epub 2016 Oct 20.
PubMed 27840739
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: a systematic review and meta-analysis. Lancet Neurol. 2017 Oct;16(10):797-812. doi: 10.1016/S1474-4422(17)30278-8. Epub 2017 Sep 12.
PubMed 28920886
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 One. 2011;6(5):e19843. doi: 10.1371/journal.pone.0019843. Epub 2011 May 17.
PubMed 21611198
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/s00415-016-8127-y. Epub 2016 May 3.
PubMed 27142714
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 quantitative optical coherence tomography studies. Neurology. 2016 Jun 14;86(24):2303-9. doi: 10.1212/WNL.0000000000002774. Epub 2016 May 25.
PubMed 27225223
Mendez-Gomez JL, Pelletier A, Rougier MB, Korobelnik JF, Schweitzer C, Delyfer MN, Catheline G, Monferme S, Dartigues JF, Delcourt C, Helmer C. Association of Retinal Nerve Fiber Layer Thickness With Brain Alterations in the Visual and Limbic Networks in Elderly Adults Without Dementia. JAMA Netw Open. 2018 Nov 2;1(7):e184406. doi: 10.1001/jamanetworkopen.2018.4406.
PubMed 30646353

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Retinal Thickness as a Potential Biomarker of Neurodegeneration and Early Cognitive Impairment in Patients With Multiple Sclerosis
ClinicalTrials.gov ID: NCT04153773
Acronym / sponsor ID: Mansoura University Hospital 2
Conditions: Multiple Sclerosis
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Mansoura University HospitalUniversity, hospital or other
Study start: 1 Aug 2018 (actual)
Primary completion: 1 Jun 2019 (actual)
Study completion: 1 Sep 2019 (actual)
First posted: 6 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Group 1	–	Diagnostic Test: OCT60 Patient
Group 2	–	Diagnostic Test: OCT30 Control subject

Who may qualify

Ages: 20 to 45 years
Sex: All
Age groups: Adult
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.

Key inclusion criteria (2 listed)

60 MS patients diagnosed according to the revised McDonald criteria 2010 were included
30 healthy subjects with age and sex match control group.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OCTAlso: EDSS, Cognitive assessmentThe 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).	Diagnostic test	Group 1, Group 2

Primary outcome

Optical coherence tomography
Time frame: 24-48 hours
OCT imaging was performed by spectral domain-optical coherence tomography to assess the retinal thickness.

2 secondary outcomes

Cognitive assessment
Time frame: 24-48 hours
Expanded Disability Status Scale (EDSS)
Time frame: 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
Background: PubMed 22266522Balk 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.
Results publication: PubMed 30410033Filippi 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.
Results publication: PubMed 30303036Kalb R, Beier M, Benedict RH, Charvet L, Costello K, Feinstein A, Gingold J, Goverover Y, Halper J, Harris C, Kostich L, Krupp L, Lathi E, LaRocca N, Thrower B, DeLuca J. Recommendations for cognitive screening and management in multiple sclerosis care. Mult Scler. 2018 Nov;24(13):1665-1680. doi: 10.1177/1352458518803785. Epub 2018 Oct 10.
Results publication: PubMed 25662900Rocca 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. doi: 10.1016/S1474-4422(14)70250-9. Epub 2015 Feb 4.
Results publication: PubMed 27986875Rocca 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.0000000000003542. Epub 2016 Dec 16.
Results publication: PubMed 26585439Kappos L, De Stefano N, Freedman MS, Cree BA, Radue EW, Sprenger T, Sormani MP, Smith T, Haring 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 sclerosis. Mult Scler. 2016 Sep;22(10):1297-305. doi: 10.1177/1352458515616701. Epub 2015 Nov 19.
Results publication: PubMed 31059539Perez Del Palomar A, Cegonino J, Montolio A, Orduna E, Vilades E, Sebastian 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(5):e0216410. doi: 10.1371/journal.pone.0216410. eCollection 2019.
Results publication: PubMed 27011339Martinez-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, Zubizarreta I, Andorra M, Sanchez-Dalmau B, Saiz A, Bermel R, Klistorner A, Petzold A, Schippling S, Costello F, Aktas O, Vermersch P, Oreja-Guevara C, Comi G, Leocani L, Garcia-Martin E, Paul F, Havrdova E, Frohman E, Balcer LJ, Green AJ, Calabresi PA, Villoslada P; IMSVISUAL consortium. Retinal thickness measured with optical coherence tomography and risk of disability worsening in multiple sclerosis: a cohort study. Lancet Neurol. 2016 May;15(6):574-84. doi: 10.1016/S1474-4422(16)00068-5. Epub 2016 Mar 18.
Results publication: PubMed 23165340London 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.
Results publication: PubMed 27840739Satue 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 Ophthalmol. 2016;2016:8503859. doi: 10.1155/2016/8503859. Epub 2016 Oct 20.
Results publication: PubMed 28920886Petzold 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: a systematic review and meta-analysis. Lancet Neurol. 2017 Oct;16(10):797-812. doi: 10.1016/S1474-4422(17)30278-8. Epub 2017 Sep 12.
Results publication: PubMed 21611198Serbecic 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 One. 2011;6(5):e19843. doi: 10.1371/journal.pone.0019843. Epub 2011 May 17.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Esmael M Ahmed, MD principal investigator

Assistant Prof of Neurology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Mansoura University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optical coherence tomography (time frame: 24-48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04153773, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.