Recruiting

WB-EMS

Sponsor:

University of Missouri-Columbia

Code:

NCT07478172

Conditions

Neuromuscular Diseases (NMD)

Amyotrophic Lateral Sclerosis

Myasthenia Gravis

Lambert-eaton Myasthenic Syndrome

Primary Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Whole-body Electrical Muscle Stimulation Exercise

Study Details

Brief 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.

Conditions

Neuromuscular Diseases (NMD)

Amyotrophic Lateral Sclerosis

Myasthenia Gravis

Lambert-eaton Myasthenic Syndrome

Primary Lateral Sclerosis

Study ID

NCT07478172

Start date

Mar 10, 2026

Status verified date

Mar, 2026

Completion date

Jan 7, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adults with Neuromuscular Disease

Participants will complete 1-2 WB-EMS Exercise visits per week for 4-8 weeks. Participants in this study will only perform Level 1 exercise programs in the "Strength" Training Mode. These programs are 20-minute videos led by exercise professionals. 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"). While the participant is following along with the video, they will be monitored and stimulation levels adjusted based on participant responses. Monitoring includes maintenance of moderate intensity level rate of perceived exertion and provision of verbal or tactile cues as needed to prompt biomechanically safe performance of each exercise movement. The exercise program (and thereby the stimulation) can be paused at any time by simply apping anywhere on the iPad screen.

Interventions

Whole-body Electrical Muscle Stimulation Exercise

Katalyst is a fitness device that delivers Whole-body Electrical Muscle Stimulation in conjunction with exercise programs (WB-EMS Exercise). After donning a base layer consisting of fitted shorts and shirt, a vest, shorts, and arm straps with integrated electrodes mapped to major muscle groups (biceps, triceps, pectorals, abdominals, periscapular musculature, paraspinal musculature, gluteus musculature, quadriceps, and hamstrings) are donned. The suit connects to an impulse pack that communicates with the Katalyst iPad App to deliver the programmed stimulation to the participant. Within the Katalyst App, there are leveled exercise programs where low levels (i.e. Level 1 and 2) are simple movements and higher levels (i.e. Levels 3, 4, and 5) have more complex and dynamic movements. There is complete user control of the stimulation level of each individual muscle group to tailor to participant responses and tolerance.

Primary outcome measure

  • Mean change from baseline in motor unit firing rates using decomposition electromyography (dEMG) [ Time Frame: Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11). ]
  • Mean change from baseline in motor evoked potentials using transcranial magnetic stimulation (TMS) [ Time Frame: Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11). ]
  • Mean change from baseline in compound muscle action potential ampliutde using standard nerve conduction study technique [ Time Frame: Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11). ]
  • Mean change from baseline in timed functional tests [ Time Frame: Measured 4-7 days prior to the start of intervention (Week 1) and 4-7 days after 4 weeks of intervention (Week 6 and Week 11). ]

Central Contacts and Locations

Central contacts

Kristina M Kelly, DPT, MS, EdM

573-884-2596kristina.kelly@health.missouri.edu

W. David Arnold, MD

573-884-2924

Locations

NextGen Precision Health Building, Clinical and Translational Science Unit

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Manny Morales

573-882-8571moralesman@missouri.edu

Stacee Baker

bakersa@health.missouri.edu

Principal Investigator:

Kristina M Kelly, DPT, MS

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • Neuromuscular Disease
  • Electrical Stimulation
  • Whole Body stimulation
  • Exercise intervention

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 2026-03-17.