Multiple Sclerosis Journal - Experimental, Translational and Clinical, 2022
Background Eighty-five percent of people with multiple sclerosis (MS) incur gait impairments debi... more Background Eighty-five percent of people with multiple sclerosis (MS) incur gait impairments debilitating enough to significantly impact their function. Objectives The aim of this study was to determine if a novel combination of intermuscular electrical stimulation, followed by functional electrical stimulation combined with supported bodyweight treadmill training, would improve gait, decrease spasticity and fatigue, and improve muscle strength. Methods Using a pre-post experimental design, we implemented this combination six-week protocol in 16 individuals with MS. We completed summary statistics and longitudinal pre-post results using Wilcoxon sign rank tests with Bonferroni adjustment. Results Participants responded with median increases of 29.4 feet ( p
Objective: To assess the safety/tolerability of opicinumab vs. placebo in participants with relap... more Objective: To assess the safety/tolerability of opicinumab vs. placebo in participants with relapsing multiple sclerosis (MS) when used chronically and concurrently with interferon (IFN) beta-1a. Background: Opicinumab (anti-LINGO-1; BIIB033) is a human monoclonal antibody candidate MS reparative agent that blocks LINGO-1, a CNS-specific negative regulator of myelination and neuroaxonal regeneration. Design/Methods: SYNERGY (NCT01864148) was a randomized, multicenter, double-blind, placebo-controlled study. Eligible participants were aged 18–58 years with a diagnosis of relapsing-remitting (RRMS) or secondary progressive MS (SPMS) and disease activity in the previous year. Disease activity for RRMS was defined as ≥2 distinct episodes of: clinical relapse, gadolinium-positive (Gd+) lesion or new T2 lesion on brain/spinal cord MRI; for SPMS it was ≥1 occurrences of clinical relapse or Gd+ lesion on brain/spinal cord MRI. Participants were randomized to 3, 10, 30 or 100 mg/kg opicinuma...
Annals of Clinical and Translational Neurology, 2021
The CHORDS trial evaluated ocrelizumab (OCR) in patients with relapsing‐remitting multiple sclero... more The CHORDS trial evaluated ocrelizumab (OCR) in patients with relapsing‐remitting multiple sclerosis who had a suboptimal response to previous disease‐modifying treatment. The objective of the present study was to assess the safety of shorter OCR infusions in a substudy of CHORDS. After completing four doses of OCR per initial US prescribing recommendations in the main study, participants in the substudy (N = 129) received a fifth dose over a 2‐h duration (vs. 3.5 h). Infusion‐related reactions occurred in 12.4% of patients. None were severe, life‐threatening or led to treatment discontinuation. Shorter infusion time did not change the safety profile of OCR. Clinicaltrials.gov (NCT0237856).
The acute and chronic effects of whole-body vibration (WBV) on balance, postural stability, and m... more The acute and chronic effects of whole-body vibration (WBV) on balance, postural stability, and mobility were evaluated in 21 women with relapsing-remitting multiple sclerosis (MS) randomly assigned to control (n = 9) or experimental (n = 12) groups. To assess acute responses, outcome variables were assessed before and immediately after a session of WBV (five 30-second bouts of vibration; frequency 30 Hz; amplitude 3 mm; 1-minute rest intervals) during their first visit (week 1) using field (Timed-Up and Go; 500-m walk; Berg Balance Scale) and laboratory tests (NeuroCom Balance Master and EquiTest System—Sensory Organization Test, Adaptation Test, Limits of Stability, Modified Clinical Test for Sensory Integration of Balance, Unilateral Stance, Tandem Walk, Step/Quick Turn). Acute responses were also measured after their fifth visit for only the Adaptation and Sensory Organization tests. For the chronic responses, participants were exposed to the WBV protocol once a week, for a tota...
Background In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinic... more Background In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinical and MRI outcomes versus subcutaneous interferon beta-1a over 3 years in treatment-naive patients with relapsing–remitting MS. Here, we assess efficacy and safety of alemtuzumab over 12 years in CAMMS223 patients who enrolled in the CAMMS03409 extension (NCT00930553), with available follow-up through the subsequent TOPAZ extension (NCT02255656). Methods In CAMMS223, patients received 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days); 22% received a third course. In the open-label, nonrandomized extensions, patients could receive as-needed additional alemtuzumab or other disease-modifying therapies. Results Of 108 alemtuzumab-treated patients in CAMMS223, 60 entered the CAMMS03409 extension; 33% received a total of 2 alemtuzumab courses, and 73% received no more than 3 courses through Year 12. Over 12 years, annualized relapse rate was 0.09, 71% of patients ha...
A prospective, randomized, three-arm, evaluator blinded study to demonstrate the feasibility of a... more A prospective, randomized, three-arm, evaluator blinded study to demonstrate the feasibility of a telerehabilitation (TR) program in individuals with ambulatory deficits secondary to Multiple Sclerosis (MS) and evaluate its efficacy when compared to conventional on-site physical therapy (PT) was completed. Thirty participants were evaluated at baseline and randomized to one of three groups with intervention lasting 8 weeks: Group 1 (control)- customized unsupervised home-based exercise program (HEP) 5 days a week; Group 2 (TR)- remote PT supervised via audio/visual real-time telecommunication twice weekly; Group 3 (PT)- in-person PT at the medical facility twice weekly. Outcomes included patient reported outcomes (PROs) obtained through questionnaires, and measurements of gait and balance performed with bedside tests and a computerized system. Functional gait assessment improved from baseline in all three groups. There were no significant differences between the TR and the conventio...
Objective To review instruments used to assess disease stability or progression in persons with m... more Objective To review instruments used to assess disease stability or progression in persons with multiple sclerosis (pwMS) that can guide clinicians in optimizing therapy. Methods A non-systematic review of scientific literature was undertaken to explore modalities of monitoring symptoms and the disease evolution of MS. Results Multiple outcome measures, or tools, have been developed for use in MS research as well as for the clinical management of pwMS. Beginning with the Expanded Disability Status Scale, introduced in 1983, clinicians and researchers have developed monitoring modalities to assess all aspects of MS and the neurological impairment it causes. Conclusions Much progress has been made in recent decades for the management of MS and for the evaluation of disease progression. New technology, such as wearable sensors, will provide new opportunities to better understand changes in function, dexterity, and cognition. Essential work over the decades since EDSS was introduced con...
International Journal of Environmental Research and Public Health
Lower limb asymmetries have been observed in persons with multiple sclerosis (PwMS), and have bee... more Lower limb asymmetries have been observed in persons with multiple sclerosis (PwMS), and have been associated with mobility impairment. An incremental cycling test was performed on a cycle ergometer to determine peak power output (PPO) and peak oxygen consumption (VO2peak). Then, participants cycled at 50%, 60%, and 70% of their PPO to assess the contribution of each lower limb to power production. Two-way repeated measures ANOVA was used to detect group × intensity differences in power production asymmetry. Eight PwMS and six healthy individuals (Non-MS) completed the study. No statistically significant (p > 0.05) group × intensity interactions or main effects were present when examining between-limb differences in power production. The current data do not indicate a statistically significant difference in power production asymmetry between groups and exercise intensities. Previous research has established a 10% difference between contralateral limbs as a threshold for asymmetry...
Multiple Sclerosis Journal - Experimental, Translational and Clinical, 2022
Background Eighty-five percent of people with multiple sclerosis (MS) incur gait impairments debi... more Background Eighty-five percent of people with multiple sclerosis (MS) incur gait impairments debilitating enough to significantly impact their function. Objectives The aim of this study was to determine if a novel combination of intermuscular electrical stimulation, followed by functional electrical stimulation combined with supported bodyweight treadmill training, would improve gait, decrease spasticity and fatigue, and improve muscle strength. Methods Using a pre-post experimental design, we implemented this combination six-week protocol in 16 individuals with MS. We completed summary statistics and longitudinal pre-post results using Wilcoxon sign rank tests with Bonferroni adjustment. Results Participants responded with median increases of 29.4 feet ( p
Objective: To assess the safety/tolerability of opicinumab vs. placebo in participants with relap... more Objective: To assess the safety/tolerability of opicinumab vs. placebo in participants with relapsing multiple sclerosis (MS) when used chronically and concurrently with interferon (IFN) beta-1a. Background: Opicinumab (anti-LINGO-1; BIIB033) is a human monoclonal antibody candidate MS reparative agent that blocks LINGO-1, a CNS-specific negative regulator of myelination and neuroaxonal regeneration. Design/Methods: SYNERGY (NCT01864148) was a randomized, multicenter, double-blind, placebo-controlled study. Eligible participants were aged 18–58 years with a diagnosis of relapsing-remitting (RRMS) or secondary progressive MS (SPMS) and disease activity in the previous year. Disease activity for RRMS was defined as ≥2 distinct episodes of: clinical relapse, gadolinium-positive (Gd+) lesion or new T2 lesion on brain/spinal cord MRI; for SPMS it was ≥1 occurrences of clinical relapse or Gd+ lesion on brain/spinal cord MRI. Participants were randomized to 3, 10, 30 or 100 mg/kg opicinuma...
Annals of Clinical and Translational Neurology, 2021
The CHORDS trial evaluated ocrelizumab (OCR) in patients with relapsing‐remitting multiple sclero... more The CHORDS trial evaluated ocrelizumab (OCR) in patients with relapsing‐remitting multiple sclerosis who had a suboptimal response to previous disease‐modifying treatment. The objective of the present study was to assess the safety of shorter OCR infusions in a substudy of CHORDS. After completing four doses of OCR per initial US prescribing recommendations in the main study, participants in the substudy (N = 129) received a fifth dose over a 2‐h duration (vs. 3.5 h). Infusion‐related reactions occurred in 12.4% of patients. None were severe, life‐threatening or led to treatment discontinuation. Shorter infusion time did not change the safety profile of OCR. Clinicaltrials.gov (NCT0237856).
The acute and chronic effects of whole-body vibration (WBV) on balance, postural stability, and m... more The acute and chronic effects of whole-body vibration (WBV) on balance, postural stability, and mobility were evaluated in 21 women with relapsing-remitting multiple sclerosis (MS) randomly assigned to control (n = 9) or experimental (n = 12) groups. To assess acute responses, outcome variables were assessed before and immediately after a session of WBV (five 30-second bouts of vibration; frequency 30 Hz; amplitude 3 mm; 1-minute rest intervals) during their first visit (week 1) using field (Timed-Up and Go; 500-m walk; Berg Balance Scale) and laboratory tests (NeuroCom Balance Master and EquiTest System—Sensory Organization Test, Adaptation Test, Limits of Stability, Modified Clinical Test for Sensory Integration of Balance, Unilateral Stance, Tandem Walk, Step/Quick Turn). Acute responses were also measured after their fifth visit for only the Adaptation and Sensory Organization tests. For the chronic responses, participants were exposed to the WBV protocol once a week, for a tota...
Background In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinic... more Background In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinical and MRI outcomes versus subcutaneous interferon beta-1a over 3 years in treatment-naive patients with relapsing–remitting MS. Here, we assess efficacy and safety of alemtuzumab over 12 years in CAMMS223 patients who enrolled in the CAMMS03409 extension (NCT00930553), with available follow-up through the subsequent TOPAZ extension (NCT02255656). Methods In CAMMS223, patients received 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days); 22% received a third course. In the open-label, nonrandomized extensions, patients could receive as-needed additional alemtuzumab or other disease-modifying therapies. Results Of 108 alemtuzumab-treated patients in CAMMS223, 60 entered the CAMMS03409 extension; 33% received a total of 2 alemtuzumab courses, and 73% received no more than 3 courses through Year 12. Over 12 years, annualized relapse rate was 0.09, 71% of patients ha...
A prospective, randomized, three-arm, evaluator blinded study to demonstrate the feasibility of a... more A prospective, randomized, three-arm, evaluator blinded study to demonstrate the feasibility of a telerehabilitation (TR) program in individuals with ambulatory deficits secondary to Multiple Sclerosis (MS) and evaluate its efficacy when compared to conventional on-site physical therapy (PT) was completed. Thirty participants were evaluated at baseline and randomized to one of three groups with intervention lasting 8 weeks: Group 1 (control)- customized unsupervised home-based exercise program (HEP) 5 days a week; Group 2 (TR)- remote PT supervised via audio/visual real-time telecommunication twice weekly; Group 3 (PT)- in-person PT at the medical facility twice weekly. Outcomes included patient reported outcomes (PROs) obtained through questionnaires, and measurements of gait and balance performed with bedside tests and a computerized system. Functional gait assessment improved from baseline in all three groups. There were no significant differences between the TR and the conventio...
Objective To review instruments used to assess disease stability or progression in persons with m... more Objective To review instruments used to assess disease stability or progression in persons with multiple sclerosis (pwMS) that can guide clinicians in optimizing therapy. Methods A non-systematic review of scientific literature was undertaken to explore modalities of monitoring symptoms and the disease evolution of MS. Results Multiple outcome measures, or tools, have been developed for use in MS research as well as for the clinical management of pwMS. Beginning with the Expanded Disability Status Scale, introduced in 1983, clinicians and researchers have developed monitoring modalities to assess all aspects of MS and the neurological impairment it causes. Conclusions Much progress has been made in recent decades for the management of MS and for the evaluation of disease progression. New technology, such as wearable sensors, will provide new opportunities to better understand changes in function, dexterity, and cognition. Essential work over the decades since EDSS was introduced con...
International Journal of Environmental Research and Public Health
Lower limb asymmetries have been observed in persons with multiple sclerosis (PwMS), and have bee... more Lower limb asymmetries have been observed in persons with multiple sclerosis (PwMS), and have been associated with mobility impairment. An incremental cycling test was performed on a cycle ergometer to determine peak power output (PPO) and peak oxygen consumption (VO2peak). Then, participants cycled at 50%, 60%, and 70% of their PPO to assess the contribution of each lower limb to power production. Two-way repeated measures ANOVA was used to detect group × intensity differences in power production asymmetry. Eight PwMS and six healthy individuals (Non-MS) completed the study. No statistically significant (p > 0.05) group × intensity interactions or main effects were present when examining between-limb differences in power production. The current data do not indicate a statistically significant difference in power production asymmetry between groups and exercise intensities. Previous research has established a 10% difference between contralateral limbs as a threshold for asymmetry...
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