Recruiting

Electrical Muscle Stimulation

Sponsor:

University of Missouri-Columbia

Code:

NCT06064695

Conditions

Generalized Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Whole-body Electrical Muscle Stimulation Exercise

Study Details

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.

Conditions

Generalized Myasthenia Gravis

Study ID

NCT06064695

Start date

Jul 12, 2023

Status verified date

Apr, 2025

Completion date

Aug, 2025

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Whole-body Electrical Muscle Stimulation (WB-EMS) Exercise

Participants with MG will receive the WB-EMS Exercise intervention 2 times per week for 4 weeks. Participants will only perform Level 1 exercise programs (simple movements) in the "Strength" Training Mode. These programs are 20-minute videos led by exercise professionals. They are full-body workouts. They consist of 10-12 exercises performed for 14 repetitions. Each repetition takes 4 seconds to complete (the time that the stimulation is "on") and is followed by a 4 second rest (the time that the stimulation is "off"). All exercises occur in a double-limb stance position. Most exercises occur with feet in wide base of support, hips width or more apart. All exercises are modifiable by the healthcare professional administering and monitoring the intervention based on participant's safe and available range of motion (i.e. arm movements, torso positions, extent of knee bend).

Healthy Control participants will not complete the intervention.

Interventions

Whole-body Electrical Muscle Stimulation Exercise

This is a fitness device that delivers whole-body electrical muscle stimulation in conjunction with exercise programs using an iPad App. The stimulation suit (fitted shorts/shirt, vest, leg straps, arm straps) will be donned with the assistance of trained research personnel. Muscle groups stimulated include biceps, triceps, pectorals, abdominals, periscapular musculature, paraspinal musculature, gluteus musculature, quadriceps, and hamstrings. The stimulation level of each individual muscle group can be tailored to participant responses and tolerance (i.e. stimulation of the quadriceps and biceps can occur at different settings). While the participant is following along with the video, a qualified health care professional will be monitoring and adjusting the stimulation levels based on participant responses; rate of perceived exertion will also be monitored to ensure safe moderate intensity levels are maintained.

Primary outcome measure

  • Mean change from baseline in single fiber electromyography (SFEMG) jitter [ Time Frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention ]
  • Mean change from baseline in the linear change in performance during the six-minute walk test (6MWT) [ Time Frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention ]
  • Mean change from baseline in the linear change in performance during the arm movement test (AMT) [ Time Frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention ]

Central Contacts and Locations

Locations

University of Kansas Clinical Research Center

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Fairway Clinical and Translational Research Unit

913-588-1227

Principal Investigator:

Mamatha Pasnoor, MD

NextGen Precision Health Building, Clinical and Translational Science Unit

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Principal Investigator:

Kristina M Kelly, DPT

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Apr 10, 2025

Last verified

Apr, 2025

Keywords

  • Exercise
  • Electrical Stimulation
  • Fatigue
  • Neuromuscular Junction Pathology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2025-04-10.