Health TrialsbyHealthPanel

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

ConditionsNeuromuscular Diseases (NMD)Amyotrophic Lateral SclerosisMyasthenia GravisLambert-eaton Myasthenic SyndromePrimary Lateral SclerosisSpinal Muscular AtrophyCharcot Marie Tooth Disease (CMT)Fascioscapulohumeral Muscular DystrophyInclusion Body MyositisMitochondrial MyopathyNemaline MyopathyCentronuclear MyopathyPostpolio SyndromePompe Disease (Late-onset)Chronic Inflammatory Demyelinating PolyneuropathyHereditary Spastic ParaplegiaPostural Orthostatic Tachycardia Syndrome (POTS)Progressive Muscular Atrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri-Columbia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Adults with Neuromuscular DiseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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).
2

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.

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).
3

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.

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).
4

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).

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).

Secondary outcomes

1

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

The Fatigue Severity Scale (FSS) is a patient-reported outcome that assesses the impact of perceived fatigue on a person's life over the prior 7-day period. It consists of 9 statements rated on a 1-7 scale with 1 indicating "strongly disagree" with the statement and 7 indicating "strongly agree". The max score is 63 where higher values indicate more impact of perceived fatigue

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).
2

Mean change from baseline in severity of pain and impact of pain on daily life

The Brief Pain Inventory (BPI) is a patient-reported outcome that assesses the severity of pain and impact of pain on daily life over the prior 7-day period. It consists of 9 statements rated on a 1-10 scale with 1 indicating "no pain" or "no interference"and 10 indicating "pain as bad as you can imagine" or "completely interferes".

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).
3

Mean change from baseline in the impact of the participant's neuromuscular condition

The Individualized Neuromuscular Quality of Life Questionnaire (INQoL) is a patient-reported outcome that assesses how the participant's neuromuscular condition affects them. There are questions about symptoms, physical ability, independence, relationships, emotional state, body image, and treatments. It consists of 45 items across 10 sections using a scale of 0-6 or 1-7. Raw scores from items in each section are summed, transformed, and converted into a 0-100 score where higher scores indicate worse quality of life.

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).
4

Mean change from baseline on the broad jump test

The broad jump test is a measure of lower extremity power. Participants will perform a two-legged jump for distance. Three trials are performed and averaged.

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).

Other outcomes

Sponsors and contacts

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University of Missouri-Columbia

Lead sponsor

Source ClinicalTrials.gov
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