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New treatment option for Generalized Myasthenia Gravis
Official title Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis
ClinicalTrials.gov ID: NCT06064695
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
You likely can't join if
- for Participants with MG:
- Concurrent participation in another treatment 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
See the full eligibility criteria
Who can join
- 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...
What rules you out
- for Participants with MG:
- Concurrent participation in another treatment 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...
- 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...
- 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 treatment 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Fairway, Kansas, United States
- Columbia, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fairway, Kansas, United States; Columbia, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.