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.
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.
Study Type
OBSERVATIONAL
Enrollment
60
Buffalo General Hospital, D3
Buffalo, New York, United States
Expanded Disability Status Scale Score (EDSS)
The Expanded Disability Status Scale (EDSS). 0-10 scale with higher scores indicating more severe disability.
Time frame: 0, 12, and 24 months
Timed 25-foot Walk.
Time it takes in seconds for patient to walk 25 feet. Higher times indicate slower ambulation.
Time frame: 0, 12, and 24 months
Nine-hole Peg Test
The Nine-Hole Peg test is a measure of manual dexterity, where the time in seconds that it takes for patient to fill pegboard holes with pegs and remove them is recorded. Longer times indicate slower motor ability. The range in seconds to complete the nine-hole peg test ranges from 0-seconds to the ceiling value of 300 seconds.
Time frame: 0, 12, and 24 months
California Verbal Learning Test 2nd Edition Total Learning Score
A measure of verbal learning and memory. Patient is read a list of 16 words 5 times and asked to recall the list each time. Score 0-80 with higher scores indicating better performance.
Time frame: 0, 12, and 24 months
Brief Visuospatial Memory Test Revised Total Learning Score
A measure of visual-spatial learning and memory. Patient is shown a display 3 times and asked to recall figures from the display. Score 0-36 with higher scores indicating better performance.
Time frame: 0, 12, and 24 months
Symbol Digit Modalities Test Total Correct
A measure of cognitive processing speed. Patient is shown a key with symbol-digit pairings and several rows of symbols with empty boxes beneath them. Patient is asked to respond with the numbers that are paired with each of the symbols as quickly and accurately as they can. Score 0-120 with higher scores indicating better performance.
Time frame: 0, 12, and 24 months
Change in Vocational Status
Vocational Status assessed by the Buffalo Vocational Monitoring Survey (BVMS). BVMS includes four sections: \[a\] demographics and disease characteristics, \[b\] self-reported symptom inventories, \[c\] general employment information, and \[d\] work-related problems/accommodations. Vocational status (employed vs. unemployed) will be taken from this survey.
Time frame: 0, 12, and 24 months
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