The purpose of this study is to test if ublituximab changes walking functions and fall risk in people with relapsing multiple sclerosis (RMS). Twenty-five qualified people with RMS will undergo a 48-week ublituximab treatment. Before, 24 weeks into, and after the treatment, their ambulatory function, disability status, and cognition will be assessed. Additionally, they will experience large-scale slip perturbations on a treadmill under the protection of a safety harness at the last assessment. The outcome measures will be compared across the assessments to examine the effects of ublituximab on improving their walking function, disability status, cognition, and the responses to the unexpected slip perturbation.
The primary objective of this single-arm and pretest-posttest study will be to examine the effects of treatment with ublituximab on ambulatory functions during unperturbed walking and large-scale gait slips (dynamic gait stability and slip-fall) among people with relapsing MS over a 12-month treatment period. Additionally, the effects of ublituximab on disease progression and cognitive functions will be evaluated. Twenty-five qualified people with relapsing multiple sclerosis (RMS) will be enrolled to this study. Before the treatment, their ambulatory functions during regular walking will be assessed in terms of their spatiotemporal gait parameters. This assessment is considered the baseline test. Their disease progression will be evaluated by the neurological exam and serum neurofilament light chain. Their cognitive function will be tested by the Montreal Cognitive Assessment. Then, they will undergo the 48-week ublituximab treatment. At the mid-point of the treatment period, they will attend another assessment session, which is identical to the baseline session. Immediately after the 48-week treatment, the same assessments will be executed again as the baseline test. In addition, all participants will experience repeated unexpected slip perturbations while walking on a treadmill under the protection of a full-body safety harness. Their response to the the slips will be quantified by their dynamic balance, reaction times of the lower leg muscles, and adaptation rate to the repeated slips. All the measurements will be analyzed to identify the effects of ublituximab on ambulatory functions, disease progression, and cognitive status of people with relapsing multiple sclerosis. Our findings will potentially lead to earlier adoption of this highly efficacious disease-modifying treatment and thus likely improve long-term patient care outcomes. This study will uncover how ublituximab impacts ambulatory function and mobility among people with relapsing MS. This will augment our current understanding of ublituximab which focuses on the aspect of the disease progression. Given mobility is critical for people with MS to maintain their employment, independence, participation in social events, and thus the quality of life, this study will have great potential to scientifically enhance our scientific understanding of effects of ublituximab and to clinically improve patient care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The participants will receive 48 weeks of treatment with ublituximab.
Georgia State University
Atlanta, Georgia, United States
NOT_YET_RECRUITINGAtlanta Neuroscience Institute
Atlanta, Georgia, United States
RECRUITINGslip-fall
The outcome of a slip trial will be deemed a fall if the peak load cell force exceeds 30% of the body weight.
Time frame: 48 weeks
Dynamic gait stability during slip
For a slip, dynamic gait stability will be calculated at two events: the slipping foot touchdown and the recovery foot liftoff.
Time frame: 48 weeks
Dynamic gait stability during walking
Dynamic gait stability during walking will be calculated based on the theoretical framework of Feasible Stability Region.
Time frame: weeks 0, 24, and 48
Spatiotemporal gait parameters during walking
The following parameters will be determined: gait speed, step length, step width, step time, and cadence. These measurements will be used to quantify our participants' ambulatory functions.
Time frame: Weeks 0, 24, and 48
Leg muscle strength
The maximum voluntary muscle strength will be assessed during maximum voluntary contractions at bilateral knee and ankle joints on an isokinetic dynamometer.
Time frame: Weeks 0, 24, and 48
Leg Muscle Activities
The surface electromyography activity from four muscles on each leg: the tibialis anterior (TA), medial gastrocnemius (MGAS), vastus lateralis (VLAT), and biceps femoris long head (BFLH), will be recorded.
Time frame: Weeks 0, 24, and 48
Sway index
It is measured when a patient is standing still for 30 seconds under four conditions: eyes open on a firm surface, eyes closed on a firm surface, eyes open on a foam pad, and eyes closed on a foam pad.
Time frame: Weeks 0, 24, and 48
Stability index
The overall stability index during stance will be determined based on the center of pressure trace calculated from the ground reaction forces.
Time frame: Weeks 0, 24, and 48
Expanded Disability Status Scale
The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability.
Time frame: Weeks 0, 24, and 48
Multiple Sclerosis Functional Composite
The three dimensions of the multiple sclerosis functional composite (MSFC) score: lower extremity motor function, upper extremity motor function, and cognitive function, will be collected based on the guidelines and forms provided by the National MS Society.
Time frame: Weeks 0, 24, and 48
Prospective falls
Participants in both groups will keep track of any falls they experience in the 12 months after the baseline evaluation using the falls questionnaire.
Time frame: Through study completion, an average of 1 year
Serum neurofilament light chain
The serum neurofilament light chain level serves as a biological marker of neuronal damage and disease progression. It will be collected for all participants in this project.
Time frame: Weeks 0, 24, and 48
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