The objective of the clinical trial is to quantify the capacity of a translatable protocol of electrical nerve stimulation (TENS) to improve walking performance and self-reported disabilities of persons with MS. The hypothesis is that activation of sensory nerve fibers with augmented TENS promotes recovery of sensorimotor function and improves the disability status of individuals with MS. The rationale for the proposed clinical trial is that the approach provides a low-cost therapeutic strategy for persons with MS to manage walking limitations and fatigue.
The study will involve a randomized, double-blind, controlled trial. Randomization will be accomplished by recruiting two individuals with a similar level of disability at a time and flipping a coin (two persons present) to determine the group assignment (A or B) of the person who contacted the investigators first. The participants and outcome assessors will be blinded to group assignment. Both groups will receive the treatment (real or sham) during the first 4 weeks (3 sessions/week)and then there will be an 8-week follow-up period. Participants will be evaluated at weeks 0, 4, 8, and 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Commercially available device will be used to apply weak electrical currents to arm and leg muscles in each of 18 treatment sessions.
Change in Gait Speed
Time to walk 25 ft as quickly as possible
Time frame: Change from baseline at weeks 4, 8, and 12.
Change in Walking Endurance
Distance walked in 6 min when walking at a brisk pace
Time frame: Change from baseline at weeks 4, 8, and 12
Change in Dynamic Balance
Score achieved on the four components of the 14-item Mini-Balance Evaluation Systems Test (Mini-BESTest). The maximum score for each subscale are: anticipatory = 6, reactive postural control = 6, sensory orientation = 6, dynamic gait = 10. The subscales are added to provide a total score with a maximum of 28.
Time frame: Change from baseline at weeks 4, 8, and 12
Change in Patient Determined Disease Steps
A questionnaire with a self-assessment scale of disease status. The scores range from 0 = normal to 8 = bedridden.
Time frame: Change from baseline at weeks 4, 8, and 12
Change in Modified Fatigue Impact Scale
A questionnaire that assesses the impact of fatigue experienced by persons with MS. Each of the 21 items is rated from 0 = Never to 5 = Almost always. The maximum total score = 105
Time frame: Change from baseline at weeks 4, 8, and 12.
Change in MS Walking Scale-12
A 12-item, patient-rated measure of how much MS compromises walking ability. Each item is rated from 1 = Not at all to 5 = extremely. The maximum total score = 60.
Time frame: Change from baseline at weeks 4, 8, and 12.
Change in Romberg Quotient
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Ratio of the total sway area when standing with the eyes closed relative to that when the eyes are open. The test will be performed while standing on a firm surface and a foam surface.
Time frame: Change from baseline at weeks 4, 8, and 12.
Change Conditioned H-reflex Amplitude
Comparison of the percent reduction in the amplitude of the conditioned H-reflex amplitude in soleus while seated, standing with eyes open, and standing with eyes closed.
Time frame: Change from baseline at weeks 4, 8, and 12.
Change in Proprioception Tract
Change in MRI signal intensity in corticospinal tract
Time frame: Change from baseline at weeks 4, 8, and 12.
Change in Muscle Synergy Number
Non-negative matrix factorization will be used to identify the number of muscle synergies when subjects walk on a treadmill.
Time frame: Change from baseline at weeks 4, 8, and 12
Change in Force Steadiness
The coefficient of variation for force when subjects perform steady, submaximal contractions.
Time frame: Change from baseline at weeks 4, 8, and 12.
Change in Muscle Synergy TIming
The timing of the muscle synergies when subjects walk on a treadmill.
Time frame: Change from baseline at weeks 4, 8, and 12.
Change in Discharge characteristics
The mean and coefficient of variation for the times between action potentials during steady isometric contractions.
Time frame: Change from baseline at weeks 4, 8, and 12.