Faculty Bibliography
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248
Long-Term Follow-up to a Randomized Controlled Trial Comparing Peroneal Nerve Functional Electrical Stimulation to an Ankle Foot Orthosis for Patients With Chronic Stroke
BACKGROUND:Evidence supports peroneal nerve functional electrical stimulation (FES) as an effective alternative to ankle foot orthoses (AFO) for treatment of foot drop poststroke, but few long-term, randomized controlled comparisons exist. OBJECTIVE:Compare changes in gait quality and function between FES and AFOs in individuals with foot drop poststroke over a 12-month period. METHODS:Follow-up analysis of an unblinded randomized controlled trial (ClinicalTrials.gov #NCT01087957) conducted at 30 rehabilitation centers comparing FES to AFOs over 6 months. Subjects continued to wear their randomized device for another 6 months to final 12-month assessments. Subjects used study devices for all home and community ambulation. Multiply imputed intention-to-treat analyses were utilized; primary endpoints were tested for noninferiority and secondary endpoints for superiority. Primary endpoints: 10 Meter Walk Test (10MWT) and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test (6MWT), GaitRite Functional Ambulation Profile, and Modified Emory Functional Ambulation Profile (mEFAP). RESULTS:A total of 495 subjects were randomized, and 384 completed the 12-month follow-up. FES proved noninferior to AFOs for all primary endpoints. Both FES and AFO groups showed statistically and clinically significant improvement for 10MWT compared with initial measurement. No statistically significant between-group differences were found for primary or secondary endpoints. The FES group demonstrated statistically significant improvements for 6MWT and mEFAP Stair-time subscore. CONCLUSIONS:At 12 months, both FES and AFOs continue to demonstrate equivalent gains in gait speed. Results suggest that long-term FES use may lead to additional improvements in walking endurance and functional ambulation; further research is needed to confirm these findings.
PMID: 25653225
ISSN: 1552-6844
CID: 5342152
Effect of in-painting on cortical thickness measurements in multiple sclerosis: A large cohort study
A comprehensive analysis of the effect of lesion in-painting on the estimation of cortical thickness using magnetic resonance imaging was performed on a large cohort of 918 relapsing-remitting multiple sclerosis patients who participated in a phase III multicenter clinical trial. An automatic lesion in-painting algorithm was developed and implemented. Cortical thickness was measured using the FreeSurfer pipeline with and without in-painting. The effect of in-painting was evaluated using FreeSurfer's paired analysis pipeline. Multivariate regression analysis was also performed with field strength and lesion load as additional factors. Overall, the estimated cortical thickness was different with in-painting than without. The effect of in-painting was observed to be region dependent, more significant in the left hemisphere compared to the right, was more prominent at 1.5 T relative to 3 T, and was greater at higher lesion volumes. Our results show that even for data acquired at 1.5 T in patients with high lesion load, the mean cortical thickness difference with and without in-painting is ∼2%. Based on these results, it appears that in-painting has only a small effect on the estimated regional and global cortical thickness. Hum Brain Mapp 36:3749-3760, 2015. © 2015 Wiley Periodicals, Inc.
PMCID:4839289
PMID: 26096844
ISSN: 1097-0193
CID: 5348142
Effects of delayed-release dimethyl fumarate on MRI measures in the phase 3 CONFIRM study
OBJECTIVE:To evaluate the effects of oral delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) on MRI lesion activity and load, atrophy, and magnetization transfer ratio (MTR) measures from the Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis (CONFIRM) study. METHODS:CONFIRM was a 2-year, placebo-controlled study of the efficacy and safety of DMF 240 mg twice (BID) or 3 times daily (TID) in 1,417 patients with relapsing-remitting multiple sclerosis (RRMS); subcutaneous glatiramer acetate 20 mg once daily was included as an active reference comparator. The number and volume of T2-hyperintense, T1-hypointense, and gadolinium-enhancing (Gd+) lesions, as well as whole brain volume and MTR, were assessed in 681 patients (MRI cohort). RESULTS:DMF BID and TID produced significant and consistent reductions vs placebo in the number of new or enlarging T2-hyperintense lesions and new nonenhancing T1-hypointense lesions after 1 and 2 years of treatment and in the number of Gd+ lesions at week 24, year 1, and year 2. Lesion volumes were also significantly reduced. Reductions in brain atrophy and MTR changes with DMF relative to placebo did not reach statistical significance. CONCLUSIONS:The robust effects on MRI active lesion counts and total lesion volume in patients with RRMS demonstrate the ability of DMF to exert beneficial effects on inflammatory lesion activity in multiple sclerosis, and support DMF therapy as a valuable new treatment option in RRMS. CLASSIFICATION OF EVIDENCE/METHODS:This study provides Class I evidence of reduction in brain lesion number and volume, as assessed by MRI, over 2 years of delayed-release DMF treatment.
PMCID:4371413
PMID: 25681448
ISSN: 1526-632x
CID: 5348212
Regional gray matter atrophy in relapsing remitting multiple sclerosis: baseline analysis of multi-center data
Regional gray matter (GM) atrophy in multiple sclerosis (MS) at disease onset and its temporal variation can provide objective information regarding disease evolution. An automated pipeline for estimating atrophy of various GM structures was developed using tensor based morphometry (TBM) and implemented on a multi-center sub-cohort of 1008 relapsing remitting MS (RRMS) patients enrolled in a Phase 3 clinical trial. Four hundred age and gender matched healthy controls were used for comparison. Using the analysis of covariance, atrophy differences between MS patients and healthy controls were assessed on a voxel-by-voxel analysis. Regional GM atrophy was observed in a number of deep GM structures that included thalamus, caudate nucleus, putamen, and cortical GM regions. General linear regression analysis was performed to analyze the effects of age, gender, and scanner field strength, and imaging sequence on the regional atrophy. Correlations between regional GM volumes and expanded disability status scale (EDSS) scores, disease duration (DD), T2 lesion load (T2 LL), T1 lesion load (T1 LL), and normalized cerebrospinal fluid (nCSF) were analyzed using Pearson׳s correlation coefficient. Thalamic atrophy observed in MS patients compared to healthy controls remained consistent within subgroups based on gender and scanner field strength. Weak correlations between thalamic volume and EDSS (r=-0.133; p<0.001) and DD (r=-0.098; p=0.003) were observed. Of all the structures, thalamic volume moderately correlated with T2 LL (r=-0.492; P-value<0.001), T1 LL (r=-0.473; P-value<0.001) and nCSF (r=-0.367; P-value<0.001).
PMCID:4366621
PMID: 25787188
ISSN: 2211-0356
CID: 5348172
Multiple sclerosis journal : experimental, translational & clinical. 2015:1.DOI: 10.1177/2055217315577828
The relationship between objective parameters of sleep and measures of fatigue, depression, and cognition in multiple sclerosis
BACKGROUND:People with multiple sclerosis (MS) often report poor sleep, fatigue, sleepiness, depression and cognitive dysfunction. Interrelationships between symptoms and sleep are poorly understood. OBJECTIVES/OBJECTIVE:To document objective parameters of sleep measured by polysomnography (PSG) and multi-sleep latency tests (MSLTs) in patients experiencing fatigue or sleepiness and to determine whether they correlate with symptoms. METHODS:Thirty-two MS patients, not on therapy, with fatigue or sleepiness completed the Modified Fatigue Impact Scale, Fatigue Severity Scale, Epworth Sleepiness Scale, Beck Depression Index and NeuroTrax cognitive tests and underwent PSG and MSLTs. RESULTS:Sleep efficiency (SE) averaged 75.1%. wake after sleep onset (WASO), sleep onset latency and multi-sleep latency were 66.2, 43.4 and 10.43 min, respectively. Stage N3 and rapid eye movement sleep were absent in 10 and four patients, respectively. Increased limb movements were observed in eight patients. Obstructive sleep apnea was observed in 12 patients. Neither SE nor WASO correlated with fatigue or sleepiness. SE correlated with the global cognitive score and with executive function and information processing subscales. CONCLUSIONS:Overall, 30/32 MS patients reporting fatigue or sleepiness had evidence of one or more sleep disturbances. PSG should be considered in MS patients reporting fatigue or sleepiness in order to rule out treatable disturbances.
PMCID:5433423
PMID: 28607689
ISSN: 2055-2173
CID: 5342492
Multiple sclerosis, employment & cognitive testing: comparison of the predictability of SDMT and computerized cognitive testing [Meeting Abstract]
ISI:000365729400034
ISSN: 1352-4585
CID: 5343252
Multiple sclerosis, fatigue & sleep disorders: exploration of sleep latency, REM latency and total REM in a community cohort of people with multiple sclerosis reporting fatigue [Meeting Abstract]
ISI:000365729400199
ISSN: 1352-4585
CID: 5343262
Multiple sclerosis and EDSS: a walking scale with no legs [Meeting Abstract]
ISI:000365729400211
ISSN: 1352-4585
CID: 5343272
Multiple sclerosis: computerized objective gait analysis of the impact of a 6-Minute timed walk on selected gait characteristics in people with multiple sclerosis - putting long legs on the walking scale [Meeting Abstract]
ISI:000365729400212
ISSN: 1352-4585
CID: 5343282
Multiple sclerosis, cognitive function profile, & EDSS: a walking scale with cognitive problems and premature unemployment [Meeting Abstract]
ISI:000365729400221
ISSN: 1352-4585
CID: 5343292
