Dataset Information

Imaging as an Outcome Measure in Multiple Sclerosis.

ABSTRACT: Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system. Magnetic resonance imaging (MRI) is sensitive to lesion formation both in the brain and spinal cord. Imaging plays a prominent role in the diagnosis and monitoring of MS. Over a dozen anti-inflammatory therapies are approved for MS and the development of many of these medications was made possible through the use of contrast-enhancing lesions on MRI as a phase II outcome. A similar phase II outcome method for the neurodegeneration that underlies progressive courses of the disease is still unavailable. Although magnetic resonance is an invaluable tool for the diagnosis and monitoring of treatment effects in MS, several imaging barriers still exist. In general, MRI is less sensitive to gray matter lesions, lacks pathological specificity, and does not provide quantitative data easily. Several advanced imaging methods including diffusion tensor imaging, magnetization transfer, functional MRI, myelin water fraction imaging, ultra-high field MRI, positron emission tomography, and optical coherence tomography of the retina study promising ways of overcoming the difficulties in MS imaging.

SUBMITTER: Ontaneda D

PROVIDER: S-EPMC5233623 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Publications

Imaging as an Outcome Measure in Multiple Sclerosis.

Ontaneda Daniel D Fox Robert J RJ

Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics 20170101 1

Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system. Magnetic resonance imaging (MRI) is sensitive to lesion formation both in the brain and spinal cord. Imaging plays a prominent role in the diagnosis and monitoring of MS. Over a dozen anti-inflammatory therapies are approved for MS and the development of many of these medications was made possible through the use of contrast-enhancing lesions on MRI as a phase II outcome. A similar phase II outcome method f ...[more]

PMID: 27699722

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Project description:Low-contrast letter acuity (LCLA) has emerged as the leading outcome measure to assess visual disability in multiple sclerosis (MS) research. As visual dysfunction is one of the most common manifestations of MS, sensitive visual outcome measures are important in examining the effect of treatment. Low-contrast acuity captures visual loss not seen in high-contrast visual acuity (HCVA) measurements. These issues are addressed by the MS Outcome Assessments Consortium (MSOAC), including representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS. MSOAC goals are acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful to persons with MS. A critical step is elucidation of clinically relevant benchmarks, well-defined degrees of disability, and gradients of change that are clinically meaningful. This review shows that MS and disease-free controls have similar median HCVA, while MS patients have significantly lower LCLA. Deficits in LCLA and vision-specific quality of life are found many years after an episode of acute optic neuritis, even when HCVA has recovered. Studies reveal correlations between LCLA and the Expanded Disability Status Score (EDSS), Multiple Sclerosis Functional Composite (MSFC), retinal nerve fiber layer (RNFL) and ganglion cell layer plus inner plexiform layer (GCL + IPL) thickness on optical coherence tomography (OCT), brain magnetic resonance imaging (MRI), visual evoked potential (VEP), electroretinogram (ERG), pupillary function, and King-Devick testing. This review also concludes that a 7-point change in LCLA is clinically meaningful. The overall goal of this review is to describe and characterize the LCLA metric for research and clinical use among persons with MS.

Dataset Information

Imaging as an Outcome Measure in Multiple Sclerosis.

Publications

Imaging as an Outcome Measure in Multiple Sclerosis.

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