NCT07478172

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-03-10
• Primary completion: 2030-12-31
• Completion: 2031-01-07
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study