NCT06064695|RecruitingFDA Device
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Sponsor study identifier
interventional
16
1 country
2
Study Start
July 12, 2023
Actual (reported)Primary Completion
April 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
During this pilot study, the investigators will examine the effects of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) on neuromuscular junction (NMJ) transmission and fatigability in adults with Generalized Myasthenia Gravis (gMG). The investigators will also test whether a relationship exists between NMJ transmission dysfunction and fatigability in gMG, which has long been presumed but never directly assessed. Participants will undergo clinical and electrophysiologic testing before and after the WB-EMS Exercise intervention. The WB-EMS Exercise intervention will be delivered 2 times per week for 4 weeks. Long-term follow up is optional. The hypotheses are (a) that the WB-EMS exercise will improve fatigability and NMJ transmission, and (b) that NMJ transmission dysfunction is related to fatigability.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 12, 2023
Actual (reported)September 26, 2023
Actual (reported)October 3, 2023
Actual (reported)April 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mean change from baseline in single fiber electromyography (SFEMG) jitter
Single fiber electromyography (SFEMG) jitter is a measure of neuromuscular junction transmission variability; a small needle will be inserted into one of the quadriceps muscles to obtain the measurement
Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Mean change from baseline in the linear change in performance during the six-minute walk test (6MWT)
Six-minute Walk Test (6MWT) is a measure of endurance and muscle fatigability; participants will walk as far as they can in 6 minutes
Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Mean change from baseline in the linear change in performance during the arm movement test (AMT)
Arm Movement Test (AMT) is a measure of upper extremity muscle fatigability; participants will move their arm back and forth between 2 targets as many times as they can in 90 seconds
Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Mean change from baseline in the quantitative myasthenia gravis (QMG) score
Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Mean change from baseline in motor unit firing rates of the vastus lateralis using decomposition electromyography (dEMG)
Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Mean change from baseline in motor unit firing rates of the middle deltoid using decomposition electromyography (dEMG)
Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Mean change from baseline in fatigue severity scale (FSS)
Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Participants with MG will receive the WB-EMS Exercise intervention 2 times per week for 4 weeks. Participants will only perform Level 1 exercise programs (simple movements) in the "Strength" Training Mode. These programs are 20-minute videos led by exercise professionals. They are full-body workouts. They consist of 10-12 exercises performed for 14 repetitions. Each repetition takes 4 seconds to complete (the time that the stimulation is "on") and is followed by a 4 second rest (the time that the stimulation is "off"). All exercises occur in a double-limb stance position. Most exercises occur with feet in wide base of support, hips width or more apart. All exercises are modifiable by the healthcare professional administering and monitoring the intervention based on participant's safe and available range of motion (i.e. arm movements, torso positions, extent of knee bend). Healthy Control participants will not complete the intervention.
This is a fitness device that delivers whole-body electrical muscle stimulation in conjunction with exercise programs using an iPad App. The stimulation suit (fitted shorts/shirt, vest, leg straps, arm straps) will be donned with the assistance of trained research personnel. Muscle groups stimulated include biceps, triceps, pectorals, abdominals, periscapular musculature, paraspinal musculature, gluteus musculature, quadriceps, and hamstrings. The stimulation level of each individual muscle group can be tailored to participant responses and tolerance (i.e. stimulation of the quadriceps and biceps can occur at different settings). While the participant is following along with the video, a qualified health care professional will be monitoring and adjusting the stimulation levels based on participant responses; rate of perceived exertion will also be monitored to ensure safe moderate intensity levels are maintained.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Kansas Clinical Research Center
Fairway, Kansas, 66205, United States
NextGen Precision Health Building, Clinical and Translational Science Unit
Columbia, Missouri, 65211, United States
Kristina M Kelly, DPT
University of Missouri-Columbia
W. David Arnold, MD
CONTACT
First Submitted
September 26, 2023
First Posted
October 3, 2023
Study Start
July 12, 2023
Actual (reported)Primary Completion
April 2025
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 10, 2025
Record last verified: 2025-04
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Source: ClinicalTrials.gov.
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