NCT06064695Recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis
Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 26 Sept 2023
- Start date
- 12 Jul 2023
- Primary completion date
- Apr 2025
- Lead sponsor
- University of Missouri-Columbia
- Diseases
- Myasthenia gravis
- NCT number
- NCT06064695
What you commit to
- Study type: Interventional
- Planned participants: 16
- From 12 Jul 2023 to the primary completion date, Apr 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another interventional research study
- Presence of a pacemaker, metal implants, or other implanted medical devices that could impact participant safety during WB-EMS intervention
- 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
- Concurrent participation in an interventional research study
- 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
Other illness
- Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease, cardia arrhythmia, neoplasm, uncontrolled hypertension)
- 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
- Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease, cardia arrhythmia, neoplasm, uncontrolled hypertension)
- 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.
Other
- 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
- Known pregnancy at time of screening
Who the study is looking for
- 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)
- Age 18-39 years
- Ability to provide informed consent
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NextGen Precision Health Building, Clinical and Translational Science Unit Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| University of Kansas Clinical Research Center Coordinator of this site? Confirm its status | Fairway | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.