Effects of Teriflunomide (Aubagio) on Cognitive and Vocational Outcomes in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Cognitive impairment is common in MS and has devastating impact on functional activities.
      There is a great demand for medications that will enhance cognitive capacity in MS patients.
      The effect of teriflunomide on cognition and vocational capacity is unknown. The
      investigators will address these questions in a sample of 30 relapsing MS patients treated
      with teriflunomide. Cognitive impairment will be measured by calculating an information
      processing speed index and a memory composite index from conventional, validated
      neuropsychological tests as recommended by consensus opinion publications. Vocational
      performance will be monitored using a newly developed online survey called the Multiple
      Sclerosis Vocational Monitoring Survey (MSVMS). This study will elucidate the effect of
      teriflunomide on these important outcomes.
    

Detailed description: 
      Summary:

      Objectives: The primary aim of this study is to define the effect of teriflunomide (Aubagio®)
      on cognitive abilities in patients with relapsing multiple sclerosis (MS). There are two
      secondary objectives, to [a] relate changes in cognition to vocational problems, and [b]
      determine MRI correlates of change in cognition, more specifically gray-matter (GM) volume
      metrics which the investigators believe reflect neurodegeneration.

      Design: This is a prospective, observational, single-blinded, longitudinal study of
      teriflunomide effects on cognitive performance in MS patients over 24 months.
      Neuropsychological status and 3T (3 Tesla) MRI will be assessed at baseline, 12 months and 24
      months. Vocational status will be assessed every three months via the internet. Statistical
      analysis will emphasize within-subjects changes in all metrics to maximize statistical power.

      Study Population: Thirty (30) relapsing MS patients and 30 healthy controls (HC) will be
      enrolled in the study.

      Outcomes: An information processing speed index and a memory composite index will be
      calculated from conventional, validated neuropsychological tests as recommended by consensus
      opinion publications. Conventional clinical metrics for overall neurological disability will
      also be assessed. Vocational performance will be monitored using a newly developed online
      survey called the Multiple Sclerosis Vocational Monitoring Survey (MSVMS). Regional GM
      atrophy, as defined by measurement of thalamic and cortical atrophy, will serve as
      neurodegeneration outcomes.

      Significance of the research: The effect of teriflunomide on the development of cognitive
      impairment and vocational capacity is unknown. This study will elucidate the effect of
      teriflunomide on these important outcomes.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A sample of 30 relapsing MS patients new to teriflunomide therapy will be enrolled. A
        sample 30 healthy control volunteers, matched on demographics with the treated group will
        be enrolled.