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Optical coherence tomography (OCT) provides tissue morphology imagery at much higher resolution than other imaging modalities such as MRI or ultrasound, and the machines are comparatively cheaper. It is an easy technique to perform; is non-ionizing, and therefore safe. These benefits are driving a rapid transformation of OCT, from its principal application as a research tool, into an extension of the 'neurological examination' in routine office practice. Originally used in assessing the severity of tissue damage and prognosis of multiple sclerosis and various neuro-ophthalmic conditions, OCT is increasingly used in other neurological disorders such as Parkinson's disease, ALS, and Alzheimer's disease. This book is the first comprehensive review of the use of OCT in neurological diseases. The coverage includes a description of the technique and its utilization in a variety of neurologic conditions. Essential reading for neurologists, neuro-ophthalmologists, and neuroradiologists wanting an introductory account of the clinical applications of OCT.
This chapter deals with the measurement of impairment or disability for use in multiple sclerosis (MS) clinical trials from a medical model perspective, focusing on global clinical trial outcome measures. It addresses the methodological issues in measuring impairment and disability. The measures of neurological impairment and disability in MS can be grouped into four classes: biological assays, performance measures, rating scales and self-report measures. The Incapacity Status Scale and the multiple sclerosis (MS) Quality of Life Inventory are examples of such self-report measures, also called patient reported outcomes or PROs. Surrogate outcome measures have been studied in a variety of diseases and have been hoped for within the MS community. The development of the Multiple Sclerosis Functional Composite (MSFC) resulted from the analysis of a pooled data set of placebo control groups and natural history study databases.
There are four conventional magnetic resonance imaging (cMRI) components readily visible to the clinician considering the extent of multiple sclerosis (MS) pathology in individual patients that might be compared with the extent of MRI-defined pathology from group data derived from natural history or clinical trial cohorts. These include: the presence, number and quality of enhancements; the aggregate number and volume of lesions defined on T2-weighted images; the number and volume of T1-weighted hypointense lesions; and net tissue loss or atrophy. Since initially inactive subjects may not contribute much to measuring efficacy over time, many trials rely on a design including an enrichment strategy based on enhancement on one, or sometimes multiple screening MRI studies. Many consider enhancing activity to be an MRI equivalent of clinical relapse. Most studies show little or no correlation between enhancing lesions and composite disability measures at one point in time, or over a few years.
In adult breakthrough disease, treatment strategies include switching to another first-line agent, adding another agent to the on-going therapy, or switching to a second-line drug such as natalizumab or immunosuppression. Therapeutic strategies such as switch to a second-line agent are typically associated with the possibility of more severe adverse events than those seen with first-line agents, including life-threatening conditions such as progressive multifocal leukoencephalopathy (PML), leukemia, secondary cancers, or infections. The primary goal of breakthrough therapy in pediatric multiple sclerosis (MS) is to prevent disease activity and disability progression in patients who have continued disease activity despite appropriate first-line therapy. Methotrexate (MTX) is a dicarboxylic acid used in the treatment of various cancers and autoimmune diseases. Combination therapy of either first-line drugs or first-line drugs with a second-line agent is sometimes used as an approach to obtain better disease control in breakthrough MS.
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