Effects of electrical muscle stimulation exercise on adults with Myasthenia Gravis
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis
This study is testing if whole-body electrical muscle stimulation exercise can help adults with Myasthenia Gravis feel less tired and improve their muscle function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 2 sites (Fairway, Kansas and 1 other locations) |
| Trial ID | NCT06064695 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the impact of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) on neuromuscular junction (NMJ) transmission and fatigability in adults diagnosed with Generalized Myasthenia Gravis (gMG). Participants will undergo clinical and electrophysiologic assessments before and after a 4-week intervention involving WB-EMS Exercise, conducted twice a week. The study aims to clarify the relationship between NMJ transmission dysfunction and fatigability, providing insights into potential therapeutic approaches for managing gMG symptoms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with a diagnosis of Generalized Myasthenia Gravis and stable therapy for at least one month.
Not a fit: Patients with severe muscle weakness or those unable to participate in an exercise program may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of fatigability in patients with Myasthenia Gravis.
How similar studies have performed: While the approach of using electrical muscle stimulation in this context is novel, similar studies have shown promise in other neuromuscular conditions.
Eligibility criteria
Show full inclusion / exclusion 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 informed consent * 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.
Where this trial is running
Fairway, Kansas and 1 other locations
- University of Kansas Clinical Research Center — Fairway, Kansas, United States (Recruiting)
- NextGen Precision Health Building, Clinical and Translational Science Unit — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Kristina M Kelly, DPT — University of Missouri-Columbia
- Study coordinator: Kristina M Kelly, DPT
- Email: kristina.kelly@health.missouri.edu
- Phone: 573-882-8571 (email preferred)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.