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Recruiting NCT06064695

NCT06064695 Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Myasthenia Gravis

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Clinical Trial Summary
NCT ID NCT06064695
Status Recruiting
Phase
Sponsor University of Missouri-Columbia
Condition Generalized Myasthenia Gravis
Study Type INTERVENTIONAL
Enrollment 16 participants
Start Date 2023-07-12
Primary Completion 2025-04

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Whole-body Electrical Muscle Stimulation Exercise

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 16 participants in total. It began in 2023-07-12 with a primary completion date of 2025-04.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

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.

Contact & Investigator

Central Contact

Kristina M Kelly, DPT

✉ kristina.kelly@health.missouri.edu

📞 573-882-8571 (email preferred)

Principal Investigator

Kristina M Kelly, DPT

PRINCIPAL INVESTIGATOR

University of Missouri-Columbia

Frequently Asked Questions

Who can join the NCT06064695 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Generalized Myasthenia Gravis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06064695 currently recruiting?

Yes, NCT06064695 is actively recruiting participants. Contact the research team at kristina.kelly@health.missouri.edu for enrollment information.

Where is the NCT06064695 trial being conducted?

This trial is being conducted at Fairway, United States, Columbia, United States.

Who is sponsoring the NCT06064695 clinical trial?

NCT06064695 is sponsored by University of Missouri-Columbia. The principal investigator is Kristina M Kelly, DPT at University of Missouri-Columbia. The trial plans to enroll 16 participants.

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