Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults withNeuromuscular Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean change from baseline in motor unit firing rates using decomposition electromyography (dEMG)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Whole-body Electrical Muscle Stimulation Exercise (Device)
结局指标
主要结局
Mean change from baseline in motor unit firing rates using decomposition electromyography (dEMG)
时间窗: 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).
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.
Mean change from baseline in motor evoked potentials using transcranial magnetic stimulation (TMS)
时间窗: 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).
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.
Mean change from baseline in compound muscle action potential ampliutde using standard nerve conduction study technique
时间窗: 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).
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.
Mean change from baseline in timed functional tests
时间窗: 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).
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).
次要结局
- 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).)
研究者
Kristina Kelly
Assistant Research Professor
University of Missouri-Columbia