[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07478172":3,"trial-entities:NCT07478172":148,"trial-summary:NCT07478172":160},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":37,"study_type":42,"primary_purpose":43,"phases":44,"enrollment_info":46,"interventions":49,"primary_outcomes":56,"secondary_outcomes":70,"sex":86,"minimum_age":87,"maximum_age":88,"healthy_volunteers":15,"eligibility_criteria":89,"std_ages":112,"locations":115,"central_contacts":137,"overall_officials":145,"references":146,"see_also_links":147},"NCT07478172","2132650","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","RECRUITING","2031-01-07","2026-03","2026-03-17","2026-03-10","University of Missouri-Columbia","OTHER",false,"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.","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\u002Fdescent, 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.",[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36],"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",[38,39,40,41],"Neuromuscular Disease","Electrical Stimulation","Whole Body stimulation","Exercise intervention","INTERVENTIONAL","TREATMENT",[45],"NA",{"count":47,"type":48},50,"ESTIMATED",[50],{"type":51,"name":52,"description":53,"armGroupLabels":54},"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.",[55],"Adults with Neuromuscular Disease",[57,61,64,67],{"measure":58,"description":59,"timeFrame":60},"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).",{"measure":62,"description":63,"timeFrame":60},"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.",{"measure":65,"description":66,"timeFrame":60},"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.",{"measure":68,"description":69,"timeFrame":60},"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\u002Frun 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).",[71,74,77,80,83],{"measure":72,"description":73,"timeFrame":60},"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",{"measure":75,"description":76,"timeFrame":60},"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\".",{"measure":78,"description":79,"timeFrame":60},"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.",{"measure":81,"description":82,"timeFrame":60},"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.",{"measure":84,"description":85,"timeFrame":60},"Mean change from baseline in the multidirectional lunge test","The multidirectional lunge test is a measure of dynamic balance. Participants will stand in the center of an asterisk star shape taped on the floor. Participants will lunge in each of 8 directions and return to two feet in the center of the star with a single push. The distance lunged in each direction is recorded. Three trials are performed on each foot and the data averaged.","ALL","18 Years",null,{"inclusion":90,"exclusion":98,"raw_text":111},[91,92,93,94,95,96,97],"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+\u002F5 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)",[99,100,101,102,103,104,105,106,107,108,109,110],"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\u002Fcontrol (i.e. Parkinson's disease, Multiple Sclerosis, h\u002Fo 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","Inclusion Criteria:\n\n* Age 18 or older\n* 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.\n* 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.)\n* At least some anti-gravity strength in major muscle groups as assessed by manual muscle testing (i.e. 2+\u002F5 strength or better)\n* Medical clearance to participate in an exercise program\n* Ability to provide informed consent\n* 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)\n\nExclusion Criteria:\n\n* 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.\n* Concurrent participation in another interventional research study\n* Unable to tolerate 15 minutes of continuous standing with or without an assistive device\n* Presence of a pacemaker, metal implants, or other implanted medical devices that could impact participant safety during WB-EMS intervention\n* 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\n* Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease, cardia arrhythmia, neoplasm, uncontrolled hypertension)\n* Known pregnancy at time of screening; verbal screening will occur throughout the study.\n* Presence of a terminal disease (i.e. receiving hospice services)\n* 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\n* Presence of an additional neurologic conditions affecting somatosensory or motor function\u002Fcontrol (i.e. Parkinson's disease, Multiple Sclerosis, h\u002Fo stroke, TBI, SCI, ataxia, apraxia, hemiplegia, etc.)\n* Musculoskeletal condition or surgery in the past year that would confound results of exercise interventions (i.e. TKA, THA, RTC repair, spinal fusion)\n* Other medical conditions, signs, or symptoms that would interfere with study conductor interpretation of results as determined by an investigator",[113,114],"ADULT","OLDER_ADULT",[116],{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":121,"contacts":122,"geoPoint":134},"NextGen Precision Health Building, Clinical and Translational Science Unit","Columbia","Missouri","65211","United States",[123,128,131],{"name":124,"role":125,"phone":126,"email":127},"Manny Morales","CONTACT","573-882-8571","moralesman@missouri.edu",{"name":129,"role":125,"email":130},"Stacee Baker","bakersa@health.missouri.edu",{"name":132,"role":133},"Kristina M Kelly, DPT, MS","PRINCIPAL_INVESTIGATOR",{"lat":135,"lon":136},38.95171,-92.33407,[138,142],{"name":139,"role":125,"phone":140,"email":141},"Kristina M Kelly, DPT, MS, EdM","573-884-2596","kristina.kelly@health.missouri.edu",{"name":143,"role":125,"phone":144},"W. David Arnold, MD","573-884-2924",[],[],[],{"nct_id":4,"conditions":149,"biomarkers":159},[20,30,150,33,151,152,34,27,153,154,28,21,155,156,157,158,23,36,24],"Charcot-Marie-Tooth Disease","Facioscapulohumeral Muscular Dystrophy","Glycogen Storage Disease Type II","Lambert Eaton Myasthenic Syndrome","Lumbar radiculopathy","Nemaline myopathy","Non-specific Low Back Pain","Post poliomyelitis syndrome","Postural Orthostatic Tachycardia Syndrome",[],{"nct_id":4,"found":161,"summary":162,"prompt_version":172},true,{"design":163,"status":164,"heading":165,"summary":166,"follow_up":167,"word_count":168,"commitments":169,"compensation":170,"drugs_mentioned":171},"This is a single-arm pilot study, meaning all participants will receive the WB-EMS intervention. Up to 50 adults with neuromuscular diseases will be enrolled.","completed","Whole-body Electrical Muscle Stimulation for Neuromuscular Diseases","This study is looking at how Whole-body Electrical Muscle Stimulation (WB-EMS) exercise, using a device called Katalyst, affects adults with neuromuscular diseases (NMDs) like ALS, Myasthenia Gravis, and others. NMDs can make traditional exercise difficult, but WB-EMS directly stimulates muscles. Researchers want to see if this exercise can improve muscle function and physical abilities. They will measure changes in how your nerves and muscles work, your physical performance (like walking and balance), and how you feel (fatigue, pain, quality of life). Up to 50 adults will participate in supervised 20-minute WB-EMS sessions, 1-2 times a week for 4-8 weeks. The study is currently unclear on its recruitment status.","Measurements will be taken 4-7 days after 4 weeks of intervention (at Week 6 and Week 11), suggesting a follow-up period after the initial 4-week intervention.",108,"You would participate in supervised 20-minute WB-EMS exercise sessions using the Katalyst system, 1-2 times per week for 4-8 weeks. Measurements will be taken before the intervention and after 4 weeks of intervention.","Not stated in the trial record.",[],"v2"]