ClinicalTrials.gg
RecruitingNCT06064695Updated Apr 10, 2025

Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis

An interventional study of Whole-body Electrical Muscle Stimulation Exercise in Generalized Myasthenia Gravis, sponsored by University of Missouri-Columbia. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 144 studies in Myasthenia Gravis with a site in United States — 53 open to participants now, 73 under way, 25 of them phase 3. Myasthenia Gravis · United States.

Planned enrollment
83rd of 108
16 · median 56
Started
2023
with 9 others
No phase
11 of 144
3 open now
Primary completion
2025-04
later than 4 of 72 live
Registered
89th of 144
by date

Among the 144 studies in Myasthenia Gravis with a site in United States, this one is the 83rd largest by planned enrollment of the 108 interventional ones that give a count, is one of 10 that started in 2023, is one of 11 with no phase, reaches primary completion later than 4 of the 72 other live ones, and was the 89th registered.

Myasthenia Gravis

330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.

Browse Myasthenia Gravis studies →

Open to participants now

53 of the 144 studies in Myasthenia Gravis with a site in United States are open now. Recruiting first, the newest first:

48 more — sign in →

All 53 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 104 Myasthenia Gravis studies recruiting now, 64 (62%) set no upper age limit and 23 (22%) stop at 75 or younger; 16 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 144 studies in Myasthenia Gravis with a site in United States, or all of them as a file.
02

Study summary

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.

Read the detailed description

During this pilot study, the investigators will examine the effects of a novel paradigm, 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. The investigators will use single fiber electromyography (SFEMG) to capture pre- and post-treatment jitter, which measures NMJ transmission variability. The investigators will use decomposition electromyography and clinical measures to assess pre- and posttreatment fatigability of motor units and muscles. and associate these with baseline values for NMJ transmission to determine the relationship between these variables. At the conclusion of the study, expected outcomes include: (1) preliminary data regarding the efficacy of WB-EMS Exercise to address fatigability, (2) an indication of whether this type of exercise may promote NMJ remodeling, and (3) clarification of mechanistic connections between NMJ transmission and fatigability. These findings will provide new insights into mechanisms of fatigability and responses to exercise in gMG. The long-term goal is to define the effects of exercise on gMG pathophysiology and identify effective and tolerable modes of exercise that can be recommended to manage and prevent gMG-related fatigue.

03

Conditions studied

  • Generalized Myasthenia Gravis

Keywords

  • Exercise
  • Electrical Stimulation
  • Fatigue
  • Neuromuscular Junction Pathology
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria for Participants with MG:

  • Age 18 or older
  • Diagnosed with Generalized Myasthenia Gravis (gMG) via seropositive test for acetylcholine receptor (AChR) antibodies or seronegative test with clinical symptoms consistent with gMG
  • On stable MG therapy for at least 1 month
  • Ability to stand for approximately 15 minutes continuously with or without an assistive device (i.e. the length of time to stand to take a shower, complete meal preparation, wait in line at the bank, etc.)
  • Score of 1 (Mild) or 2 (Moderate) on at least one side of the "arm outstretched" and "leg outstretched" items of the QMG, demonstrating fatigability
  • At least some anti-gravity strength in major muscle groups as assessed by manual muscle testing (i.e. 2+/5 strength or better)
  • Medical clearance to participate in an exercise program
  • Ability to provide
  • Ability to conform to the requirements of the study (i.e. attendance at assessment and intervention visits, maintain current level of non-study physical activity for the duration of the study, no intention to relocate mid-study)

Exclusion Criteria for Participants with MG:

  • Concurrent participation in another interventional research study
  • Unable to tolerate 15 minutes of continuous standing with or without an assistive device
  • Regular participation in strength training (2x per week or more over the past 6 months)
  • Score of 0 (None) on all "arm outstretched" and "leg outstretched" items of the QMG
  • Presence of a pacemaker, metal implants, or other implanted medical devices that could impact participant safety during WB-EMS intervention
  • Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease, cardia arrhythmia, neoplasm, uncontrolled hypertension)
  • Known pregnancy at time of screening
  • Presence of a terminal disease (i.e. receiving hospice services)
  • Current or previous use of any drugs known to influence muscle mass or performance within 6 months; these may include but are not limited to anabolic steroids, IGF01, growth hormone, replacement androgen therapy, anti-androgen therapy
  • Presence of an additional neuromuscular or neurologic condition affecting somatosensory or motor function/control (i.e. motor neuron disease, muscle disease, peripheral neuropathy, other NMJ condition, Parkinson's disease, Multiple Sclerosis, h/o stroke, traumatic brain injury, spinal cord injury, ataxia, apraxia, hemiplegia, etc.)
  • Musculoskeletal condition or surgery in the past year that would confound results of exercise interventions (i.e. knee replacement, hip replacement, rotator cuff repair, spinal fusion)
  • Other medical conditions, signs, or symptoms that would interfere with study conduct or interpretation of results as determined by an investigator

Inclusion Criteria for Healthy Controls:

  • Age 18-39 years
  • Ability to provide informed consent

Exclusion Criteria for Healthy Controls:

  • Concurrent participation in an interventional research study
  • Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease, cardia arrhythmia, neoplasm, uncontrolled hypertension)
  • Presence of a terminal disease (i.e. receiving hospice services)
  • Current or previous use of any drugs known to influence muscle mass or performance within 6 months; these may include but are not limited to anabolic steroids, IGF01, growth hormone, replacement androgen therapy, anti-androgen therapy
  • Presence of an additional neuromuscular or neurologic condition affecting somatosensory or motor function/control (i.e. motor neuron disease, muscle disease, peripheral neuropathy, other NMJ condition, Parkinson's disease, Multiple Sclerosis, h/o stroke, TBI, SCI, ataxia, apraxia, hemiplegia, etc.)
  • Musculoskeletal condition or surgery in the past year that would confound results of exercise interventions (i.e. TKA, THA, RTC repair, spinal fusion)
  • Other medical conditions, signs, or symptoms that would interfere with study conduct or interpretation of results as determined by an investigator

Healthy controls will complete dEMG testing only during a one-time session.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Whole-body Electrical Muscle Stimulation (WB-EMS) Exercise

    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.

    Device: Whole-body Electrical Muscle Stimulation Exercise

Interventions

  • DeviceWhole-body Electrical Muscle Stimulation Exercise

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention

  2. 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

    Time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention

  3. 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

    Time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention

Secondary outcomes

  1. Mean change from baseline in the quantitative myasthenia gravis (QMG) score

    Quantitative Myasthenia Gravis (QMG) is a measure of overall disease severity; items include eye movements, swallowing, speaking, breathing test, grip strength, and neck/arm/leg endurance. Thirteen items will be rated on a scale of 0-3 where higher scores indicated greater disease severity.

    Time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention

  2. Mean change from baseline in motor unit firing rates of the vastus lateralis using decomposition electromyography (dEMG)

    Decomposition electromyography (dEMG) is a measurement of motor unit activity; a surface electrode will be placed over the vastus lateralis in the thigh and participants will be asked to activate that muscle

    Time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention

  3. Mean change from baseline in motor unit firing rates of the middle deltoid using decomposition electromyography (dEMG)

    Decomposition electromyography (dEMG) is a measurement of motor unit activity; a surface electrode will be placed over the middle deltoid in the shoulder and participants will be asked to activate that muscle

    Time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention

  4. Mean change from baseline in fatigue severity scale (FSS)

    Fatigue Severity Scale (FSS) is a patient-reported outcome measure assessing the impact of perceived fatigue on a person's life over the prior 7-day period. Nine items are rated on a scale of 1-7 where higher scores indicate more impact of perceived fatigue.

    Time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention

07

Study locations

2 of 2 sites recruiting
  • University of Kansas Clinical Research Center
    Fairway, Kansas 66205, United States
    Recruiting
    • Fairway Clinical and Translational Research Unit · Contact913-588-1227
    • Mamatha Pasnoor, MD · Principal investigator
  • NextGen Precision Health Building, Clinical and Translational Science Unit
    Columbia, Missouri 65211, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Apr 2025, 21 months after the start.

Of 35 interventional studies with no phase under Myasthenia Gravis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's planned 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2023
First posted
Oct 3, 2023
StartActual
Jul 12, 2023
Primary completionEst.
Apr 2025
CompletionEst.
Aug 2025
Last update
Apr 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06064695
Responsible party
Kristina Kelly (Assistant Research Professor, University of Missouri-Columbia) — Principal investigator
First posted
Oct 3, 2023
Start date
Jul 12, 2023
Primary completion
Apr 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Apr 10, 2025

Study contacts

Kristina M Kelly, DPT
Contact
kristina.kelly@health.missouri.edu
573-882-8571 (email preferred)
W. David Arnold, MD
Contact
Kristina M Kelly, DPT
principal investigator · University of Missouri-Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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