ClinicalTrials.gov record NCT07478172

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Single-arm pilot testing whole-body electrical muscle stimulation (WB-EMS) exercise using the Katalyst device in adults with various neuromuscular diseases. Up to 50 adults receive 20-minute supervised WB-EMS sessions 1–2 times per week for 4–8 weeks with assessments before and after the program. Key eligibility gates include age 18+, ability to stand ~15 minutes and some anti-gravity strength; people with implanted electrical devices, certain NMDs with cardiac or muscle-structure defects, pregnancy, or unstable medical conditions are excluded.

What it is studying. This study tests whether supervised WB-EMS exercise produces measurable changes in neuromuscular and physical function in adults with neuromuscular disease. Investigators measure neural excitability (transcranial magnetic stimulation), motor unit behavior (decomposition EMG), compound muscle action potentials (nerve conduction), timed functional performance, and patient-reported fatigue, pain, and quality of life, while closely monitoring safety and tolerability.

What the researchers hope to learn. To generate preliminary data on feasibility, safety, and the effects of WB-EMS on neural excitability, motor unit behavior, physical function, and patient-reported fatigue, pain, and quality of life to inform future larger clinical trials.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • Whole-body Electrical Muscle Stimulation Exercise

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

This single-arm pilot study aims to investigate the effects of a whole-body electrical muscle stimulation (WB-EMS) exercise program on neuromuscular and physical function in adults with neuromuscular disease (NMD). The background rationale is that individuals with NMD often experience significant barriers to traditional exercise due to impaired voluntary motor unit activation, leading to sedentary behavior, physical deconditioning, and worsened long-term health outcomes. WB-EMS may offer a therapeutic alternative by bypassing voluntary activation limits and directly stimulating muscle contractions through externally applied electrical currents. The intervention utilizes the Katalyst system, an FDA-cleared device being used off-label in this population, which delivers targeted stimulation to major muscle groups during synchronized exercise movements. Up to 50 adults diagnosed with various NMDs, including amyotrophic lateral sclerosis, spinal muscular atrophy, myasthenia gravis, and Charcot-Marie-Tooth disease, will be enrolled. Eligible participants must be at least 18 years old, able to stand continuously for 15 minutes with or without assistance, and have at least anti-gravity strength in major muscle groups. Key exclusion criteria include implanted electrical devices, unstable medical conditions, pregnancy, and conditions affecting muscle fiber structural integrity. The intervention consists of 20-minute supervised exercise sessions performed 1-2 times per week over 4-8 weeks, with real-time monitoring of pain, perceived exertion, and tolerability. Outcome measures include neural excitability assessed via transcranial magnetic stimulation, voluntary motor unit characteristics via decomposition electromyography, stimulated motor unit characteristics via compound muscle action potential nerve conduction study, functional performance tests (10-meter walk, timed up and go, five-time sit-to-stand, stair ascent/descent, broad jump, multidirectional lunge), and patient-reported outcomes evaluating fatigue, pain, and quality of life. This pilot study will generate critical preliminary data on the feasibility, safety, and efficacy of WB-EMS as a novel exercise modality for adults with NMD, with the goal of informing future large-scale clinical trials.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You would attend supervised 20-minute whole‑body electrical muscle stimulation (WB‑EMS) exercise sessions 1–2 times per week for 4–8 weeks wearing a suit with electrode straps; stimulation and intensity are adjusted and monitored in real time and can be paused. Before starting and after the training period you will have tests including transcranial magnetic stimulation (TMS), decomposition electromyography (dEMG), a nerve conduction study (electrical stimulation to measure muscle responses), timed functional tests (walk, sit-to-stand, stairs, jumps, lunges), and questionnaires about fatigue, pain, and quality of life. Study staff will monitor pain, perceived exertion, and tolerability during sessions. Participation requires attending assessment and intervention visits and keeping your usual non-study physical activity level for the study duration.

How the study is structured. A single-group, unmasked interventional pilot. Participants complete supervised 20-minute WB-EMS exercise sessions 1–2 times per week for 4–8 weeks using the Katalyst system. Assessments are performed before the intervention and again after the program and include TMS, EMG, nerve conduction studies, timed functional tests, and questionnaires. There is continuous safety monitoring during exercise and testing.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on hereditary spastic paraplegia

This trial is also listed on this site under Pompe disease.

Clinical trials21 trials listed for hereditary spastic paraplegiaEvery trial the registry lists for hereditary spastic paraplegia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in hereditary spastic paraplegia researchLatest monthly update: September 2026. Includes: SPTSSA treatment signal. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 10, 2026
Primary completion
Dec 31, 2030 (estimated)
Study completion
Jan 7, 2031 (estimated)
Target enrollment
50 participants (estimated)
Last updated on registry
Mar 17, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Missouri-Columbia
Principal investigator
Kristina Kelly, Assistant Research Professor
University of Missouri-Columbia

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
serious adverse event
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Outcome measures
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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