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

NCT07478172 | Recruiting FDA Device

• 1 other identifier: 2132650
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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; Spinal Muscular Atrophy; Charcot Marie Tooth Disease (CMT); Fascioscapulohumeral Muscular Dystrophy; Inclusion Body Myositis; Mitochondrial Myopathy; Nemaline Myopathy; Centronuclear Myopathy; Postpolio Syndrome; Pompe Disease (Late-onset); Chronic Inflammatory Demyelinating Polyneuropathy; Hereditary Spastic Paraplegia; Postural Orthostatic Tachycardia Syndrome (POTS); Progressive Muscular Atrophy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Mean change from baseline in motor unit firing rates using decomposition electromyography (dEMG)

  Decomposition electromyography (dEMG) is a measurement of motor unit activity; a surface electrode will be placed over the vastus lateralis in the thigh and participants will be asked to activate that muscle. Participants will take standardized positions, sitting with knee at a 75-degree angle. Participants will perform three 5-second maximal voluntary isometric contractions (MVC); this will be followed by 2 contractions each at 35%, 50% and 70% MVC using a trapezoidal force matching protocol.

  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)

  Motor evoked potentials are a measure of neural excitability. They are generated by placing a magnetic coil over the skull. The output will be measured from surface electrodes over the vastus lateralis muscle in the quadriceps. We will be assessing the corticospinal pathway. Participants will take standardized positions, sitting with knee at a 75-degree angle. Participants will perform six contractions at 10% MVC, and four contractions each at 30%, 50% and 70% MVC. Magnetic pulses will be applied during each contraction.

  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

  A small amount of electrical stimulation (enough to ensure that the largest possible response is elicited) will be applied to the skin surface over the femoral nerve at the anterior hip. Surface recording electrodes will be placed over the vastus lateralis in the thigh to read out the muscle's response to the nerve stimulation; this is the compound muscle action potential. It is a measure of motor unit health.

  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

  To capture changes in time to perform common functional movements relevant to maintenance of independence for adults with neuromuscular disease, the investigators will collect data on 10-meter walk/run test, timed up and go test (rise from a chair, walk 3 meters, turn around, and return to sitting in chair at comfortable and fast speeds), 5-time sit-to-stand test (perform 5 times consecutively sitting to standing to sitting again), and 4-stair ascent and descent test (climb 4 stairs and descend 4 stairs with and without handrails).

  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).

Secondary Outcomes (5)

• Mean change from baseline in perceived fatigue on a person's life

  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 severity of pain and impact of pain on daily life

  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 the impact of the participant's neuromuscular condition

  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 on the broad jump test

  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 the multidirectional lunge test

  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).

Study Arms (1)

Adults with Neuromuscular Disease

EXPERIMENTAL

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.

Device: Whole-body Electrical Muscle Stimulation Exercise

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.

Adults with Neuromuscular Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

NextGen Precision Health Building, Clinical and Translational Science Unit

Columbia, Missouri, 65211, United States

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases; Amyotrophic Lateral Sclerosis; Myasthenia Gravis; Lambert-Eaton Myasthenic Syndrome; Motor Neuron Disease; Muscular Atrophy, Spinal; Charcot-Marie-Tooth Disease; Muscular Dystrophy, Facioscapulohumeral; Myositis, Inclusion Body; Mitochondrial Myopathies; Myopathies, Nemaline; Myopathies, Structural, Congenital; Postpoliomyelitis Syndrome; Glycogen Storage Disease Type II; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Spastic Paraplegia, Hereditary; Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Neuromuscular Junction Diseases; Autoimmune Diseases; Immune System Diseases; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Polyneuropathies; Peripheral Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Myositis; Mitochondrial Diseases; Poliomyelitis; Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Neuroinflammatory Diseases; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Metabolism, Inborn Errors; Glycogen Storage Disease; Carbohydrate Metabolism, Inborn Errors; Lysosomal Storage Diseases; Polyradiculoneuropathy; Demyelinating Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases

Central Study Contacts

Kristina M Kelly, DPT, MS, EdM

CONTACT

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

W. David Arnold, MD

CONTACT

573-884-2924

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Model Details: Enrolled participants will undergo pre-test assessments within 4-7 days before and after the intervention period. The pre-test assessment visit will be scheduled for 3.5 hours, and the post-test assessment visit for 3 hours, reflecting that the pre-test visit will incorporate consenting and screening procedures. The intervention will consist of 1-2 visits per week for 4 weeks with the option of continuing for another 4 weeks; each intervention visit will be scheduled for 1.5 hours with a target of 20 minutes of mild- to moderate-intensity exercise.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 17, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): January 7, 2031
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)