Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease

Study Identifier:
2132650
ClinicalTrials.gov Identifier:
NCT07478172
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
University of Missouri-Columbia
Recruiting

Study Details

Medical Condition
  • All Spinal Muscular Atrophies
Study Drug
    Date
    Mar 2026 - Dec 2030
    Patient Requirements
    Sex: Female & Male
    Age: 18+ years
    Requirements Information
    Inclusion and 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

    Protocol Summary

    This single-arm pilot study evaluates the effects of whole-body electrical muscle stimulation (WB-EMS) exercise on neuromuscular and physical function in adults with neuromuscular disease (NMD). Due to motor unit impairments, NMD patients often cannot tolerate traditional exercise. WB-EMS bypasses voluntary activation limits by directly stimulating muscle contractions. Up to 50 adults with conditions like ALS, SMA, and MG will undergo 20-minute supervised WB-EMS sessions (1-2 times weekly for 4-8 weeks) using the Katalyst system. Outcomes include neural excitability (TMS), motor unit behavior (EMG, NCS), functional tests (walk, balance, strength), and patient-reported fatigue, pain, and quality of life. Strict safety monitoring and exclusion criteria are in place. This study will provide preliminary data on WB-EMS as a potential exercise modality for NMD.

    Trial Locations

    Location
    Status
    Location
    NextGen Precision Health Building, Clinical and Translational Science Unit
    Columbia, Missouri, United States, 65211
    Status
    Recruiting

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