Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT06064695
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 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06064695
Study Brief:
Protocol Section:
NCT06064695