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

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT07478172
Status
Recruiting
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Conditions

  • Amyotrophic Lateral Sclerosis
  • Centronuclear Myopathy
  • Charcot Marie Tooth Disease (CMT)
  • Chronic Inflammatory Demyelinating Polyneuropathy
  • Fascioscapulohumeral Muscular Dystrophy
  • Hereditary Spastic Paraplegia
  • Inclusion Body Myositis
  • Lambert-eaton Myasthenic Syndrome
  • Mitochondrial Myopathy
  • Myasthenia Gravis
  • Nemaline Myopathy
  • Neuromuscular Diseases (NMD)
  • Pompe Disease (Late-onset)
  • Postpolio Syndrome
  • Postural Orthostatic Tachycardia Syndrome (POTS)
  • Primary Lateral Sclerosis
  • Progressive Muscular Atrophy
  • Spinal Muscular Atrophy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Whole-body Electrical Muscle Stimulation Exercise — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 10, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Jan 7, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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). ]

Central Contacts

  • Kristina M Kelly, DPT, MS, EdM
    573-884-2596
    [email protected]
  • W. David Arnold, MD
    573-884-2924

Locations (1)

FacilityCityStateZIPSite coordinators
NextGen Precision Health Building, Clinical and Translational Science UnitColumbiaMissouri65211
Manny Morales
[email protected]
573-882-8571
Stacee Baker
[email protected]
Kristina M Kelly, DPT, MS (PRINCIPAL_INVESTIGATOR)

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By research site
NextGen Precision Health Building, Clinical and Translational Science Unit· Columbia, MO

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