Whole-body electrical muscle stimulation exercise for adults with neuromuscular disease
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults withNeuromuscular Disease
This pilot tests whether short supervised sessions of whole-body electrical muscle stimulation can help nerve and muscle function and physical abilities in adults with neuromuscular diseases like ALS and myasthenia gravis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT07478172 on ClinicalTrials.gov |
What this trial studies
This is a single-arm pilot enrolling up to 50 adults with a range of neuromuscular diseases to receive supervised whole-body electrical muscle stimulation (WB-EMS) exercise using the Katalyst system. Participants will attend 20-minute sessions one to two times per week for 4–8 weeks while investigators monitor safety closely. Outcomes include measures of neural excitability (TMS), motor unit behavior (EMG, nerve conduction studies), standard functional tests for walking, balance, and strength, and patient-reported fatigue, pain, and quality of life. The device is FDA-cleared but used off-label in this population, and strict inclusion/exclusion criteria are applied to reduce risk.
Who should consider this trial
Good fit: Adults (18+) with a diagnosed neuromuscular disorder who can stand for about 15 minutes and have at least some anti-gravity muscle strength and medical clearance are ideal candidates.
Not a fit: Patients with implanted electrical devices, unstable medical conditions, severe weakness who cannot stand for 15 minutes, pregnancy, or structural muscle fiber disorders are unlikely to benefit or may be excluded for safety.
Why it matters
Potential benefit: If successful, WB-EMS could provide a safe alternative exercise option that improves strength, mobility, and quality of life for people with neuromuscular disease.
How similar studies have performed: Smaller studies of localized neuromuscular electrical stimulation have shown improvements in strength or function in other populations, but WB-EMS for heterogeneous neuromuscular disease is largely novel and untested in larger trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Diagnosed with one or more of the following neuromuscular conditions: Amyotrophic lateral sclerosis, primary lateral sclerosis, progressive muscle atrophy, spinal muscular atrophy, postpolio syndrome, inclusion body myositis, pompedisease, fascioscapulohumeral muscular dystrophy, charcot marie tooth disease, chronic inflammatory demyelinating polyneuropathy, hereditary spastic paraplegia, myasthenia gravis, lambert-eaton myasthenic syndrome, postural orthostatic tachycardia syndrome, mitochondrial myopathy, nemaline myopathy, centronuclear myopathy, lumbar radiculopathy, non-specific low back pain. * 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.) * 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: * Diagnosed with one of the following neuromuscular conditions: Becker's muscular dystrophy, Duchenne muscular dystrophy, limb-girdle muscular dystrophy, myotonic dystrophy type 1 or 2, Freidrich's ataxia, any other NMD with known or suspected cardiac involvement or muscle fiber structural integrity defects. * Concurrent participation in another interventional research study * Unable to tolerate 15 minutes of continuous standing with or without an assistive device * Presence of a pacemaker, metal implants, or other implanted medical devices that could impact participant safety during WB-EMS intervention * Presence of cochlear implant, cortical stimulator, deep brain stimulator, ventriculoperitoneal shunt, recent skull defect, seizure in the past 12 months while taking anti-epilepsy medication, or previous serious adverse event with TMS, which could impact participant safety during TMS testing * Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease, cardia arrhythmia, neoplasm, uncontrolled hypertension) * Known pregnancy at time of screening; verbal screening will occur throughout the 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 * Presence of an additional neurologic conditions affecting somatosensory or motor function/control (i.e. 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 conductor interpretation of results as determined by an investigator
Where this trial is running
Columbia, Missouri
- NextGen Precision Health Building, Clinical and Translational Science Unit — Columbia, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Kristina M Kelly, DPT, MS, EdM
- Email: kristina.kelly@health.missouri.edu
- Phone: 573-884-2596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.