Clinical and Neuroimaging Assessments for Research Studies (Including Drug Trials) in Multiple Sclerosis

Michelle L. Apperson1, Mark A. Agius1

1 Department of Neurology, University of California Davis and VA Northern California Health System (VANCHS), Sacramento, California
Publication Name:  Current Protocols in Neuroscience
Unit Number:  Unit 10.4
DOI:  10.1002/0471142301.ns1004s54
Online Posting Date:  January, 2011
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Multiple sclerosis (MS) is an immune‐mediated disorder causing inflammation and demyelination in the central nervous system. As the onset of multiple sclerosis is at a young age, it is one of the leading neurological causes of disability. Disease activity and disability can be measured by neurological assessments and by magnetic resonance imaging. The development of standardized assessments has been a very important step in clinical research in MS. Clinical research in MS has led to a better understanding of the disease itself and has resulted in exciting new therapies. The protocols provided in this unit are four basic clinical and neuroimaging assessments commonly used as outcome measures in clinical research studies of MS subjects. These step‐by‐step instructions may be used by researchers and neurologists in clinical practice to obtain objective measures of MS disease progression and response to treatments. Curr. Protoc. Neurosci. 54:10.4.1‐10.4.16. © 2011 by John Wiley & Sons, Inc.

Keywords: multiple sclerosis; clinical trials; EDSS; MSFC; MRI

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Table of Contents

  • Introduction
  • Strategic Planning
  • Basic Protocol 1: Relapse Assessment
  • Basic Protocol 2: Expanded Disability Status Scale (EDSS)
  • Basic Protocol 3: Multiple Sclerosis Functional Composite (MSFC)
  • Basic Protocol 4: Neuroimaging Assessment
  • Commentary
  • Literature Cited
  • Figures
  • Tables
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Basic Protocol 1: Relapse Assessment

  • Snellen wall chart at 20 feet (Professional Hospital Supply)
  • Hand‐held Snellen card (Professional Hospital Supply)
  • Ophthalmoscope
  • Reflex hammer
  • Safety pin
  • Tuning fork

Basic Protocol 2: Expanded Disability Status Scale (EDSS)

  • Stopwatch
  • Clearly marked 25‐foot line
  • Case record forms (see Supplemental data)
  • 9‐HPT apparatus/pegs (e.g., Smith & Nephew)
  • Dycem activity pad to stabilize 9‐HPT apparatus (10 × 14–in. Dycem, Sammons Preston)
  • Cassette tape or CD player
  • PASAT stimulus tape or CD (available from Stephen Rao, MCW Clinic at Froedtert; )
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Literature Cited

Literature Cited
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