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Analysis of Neurodegenerative Process Within Visual Ways In Multiple Sclerosis (VWIMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03656055
Recruitment Status : Unknown
Verified August 2018 by University Hospital, Lille.
Recruitment status was:  Recruiting
First Posted : September 4, 2018
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
This study will interest in the pathophysiology of silent retinal axonal loss in multiple sclerosis. Recent studies have suggested that silent retinal axonal loss (no past history of optic neuritis [ON]) may be due to inflammatory lesions within the optic radiations and a transsynaptic degenerative process. The objective is to measure the exact role of silent optic nerve lesion in the occurrence of silent retinal axonal loss by performing OCT, brain and optic nerve MRI in a cohort of patients without recent disease activity.

Condition or disease
Multiple Sclerosis

Detailed Description:

This study will interest in the neurodegenerative process reported in multiple sclerosis within the visual ways.

Symptomatic and asymptomatic retinal axonal loss in multiple sclerosis (MS) have largely been described. Many recent optical coherence tomography (OCT) studies have suggested that subclinical retinal axonal loss (no past history of optic neuritis [ON]) observed in MS mainly due to inflammatory and demyelinating lesions within the optic radiations and a retrograde transsynaptic degenerative process. None of these studies clearly tried to investigate the role of asymptomatic optic nerve lesion(s) in subclinical retinal axonal loss occurence.

The main objective of the study is to measure the exact role of silent optic nerve lesion in the occurrence of silent retinal axonal loss by performing OCT, brain and optic nerve MRI. The study will focus on a cohort of patients without recent disease activity in order to exclude or minimize the risk of recent and old lesion occurence on the visual ways, which could be a bias in our analysis.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Link Between Retinal Atrophy and Demyelinating Inflammatory Processes on Visual Pathways in Relapsing Multiple Sclerosis in Magnetic Resonance Imaging and Optical Coherence Tomography
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Study of asymptomatic retinal atrophy in multiple sclerosis and asymptomatic optic nerve demyelinating lesion [ Time Frame: Day 1 (cross-sectional study) ]

    The temporal peripapillary Retinal Nerve Fiber Layer thickness (pRNFL; quantitative data) measured on optical coherence tomography will evaluate asymptomatic retinal atrophy

    Presence of subclinical optic nerve lesion will be assessed on optic nerve MRI (3D-double inversion recovery sequence; Y/N; qualitative data) and according to clinical information (past history of optic neuritis [ON] or not). It will enable investigators to define 3 eyes' groups: eyes' group with symptomatic optic nerve lesion (ON eyes), eyes' group with asymptomatic optic nerve lesion (NON eyes with asymptomatic lesion) and eyes' group without symptomatic or asymptomatic lesion (NON eyes without lesion).

    Investigators will proceed to comparison of temporal pRNFL between NON eyes with asymptomatic lesion and NON eyes without lesion



Secondary Outcome Measures :
  1. Evaluation of the link between asymptomatic retinal atrophy in multiple sclerosis and intensity of demyelinating process all along the optic ways (from the retina to the visual cortex) [ Time Frame: Day 1 (cross-sectional study) ]

    Within NON eyes, investigators will evaluate the imaging parameters on the optic ways which is/are significantly and independently associated to temporal pRNFL (multivariate analysis)

    MRI parameters parameters included will be: length of asymptomatic optic nerve lesion; presence of lesion on chiasma, presence of lesion on optic tracts, T2 lesion burden on optic radiations, fractional anisotropy in optic radiations, volume of primary visual cortex


  2. Evaluation of the link between symptomatic retinal atrophy in multiple sclerosis and intensity of demyelinating process all along the optic ways (from the retina to the visual cortex) [ Time Frame: Day 1 (cross-sectional study) ]

    Within ON eyes, investigators will evaluate the imaging parameters on the optic ways which is/are significantly and independently associated to temporal pRNFL (multivariate analysis)

    MRI parameters parameters included will be: length of subclinical optic nerve lesion; presence of lesion on chiasma, presence of lesion on optic tracts, T2 lesion burden on optic radiations, fractional anisotropy in optic radiations, volume of primary visual cortex


  3. Evaluation of the link between retinal atrophy and visual connectivity [ Time Frame: Day 1 (cross-sectional study) ]
    Within all eyes (ON eyes + NON eyes with asymptomatic optic nerve lesion + NON eyes without asymptomatic lesion), investigators will evaluate the link between the mean temporal pRNFL of both eyes (pRNFL; quantitative data) and the strength of visual connectivity (seed based approach on resting state sequence)

  4. Evaluation of the link between visual disability and MRI parameters measuring intensity of demyelinating process all along the optic ways (from the retina to the visual cortex) [ Time Frame: Day 1 (cross-sectional study) ]

    Within all eyes (ON eyes + NON eyes with asymptomatic optic nerve lesion + NON eyes without asymptomatic lesion), investigators will evaluate the MRI parameters significantly and independently associated to visual disability.

    Visual disability will be measured by low contrast vision acuity (2.5%; unit LogMar)

    MRI parameters will be length of subclinical optic nerve lesion; presence of lesion on chiasma, presence of lesion on optic tracts, T2 lesion burden on optic radiations, fractional anisotropy in optic radiations, volume of primary visual cortex




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RRMS treated by natalizumab for more than 6 months in order to measure patients with a lower risk of relapse
Criteria

Inclusion Criteria:

  • Relapsing Remitting Multiple Sclerosis (RRMS) patients treated by natalizumab for more than 6 months
  • JohnCunninghamVirus (JCV) index < 0.9
  • patients followed in our MS center from the beginning of the disease

Exclusion Criteria:

  • ophthalmologic diseases
  • diabetes mellitus
  • contra-indication to MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656055


Contacts
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Contact: Olivier Outteryck, MD, PhD 03 20 44 68 46 ext +33 olivier.outteryck@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, CHRU Recruiting
Lille, France
Principal Investigator: Olivier Outteryck, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Olivier Outteryck, MD, PhD University Hospital, Lille
Publications:

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03656055    
Other Study ID Numbers: 2016_32
2017-A00194-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: September 4, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
MRI
axonal loss
MS
OCT
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases