Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-27 @ 4:42 PM
Study NCT ID:
NCT02011204
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2013-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Electrical Impedance Myography (EIM) in ALS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D002607', 'term': 'Charcot-Marie-Tooth Disease'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D015417', 'term': 'Hereditary Sensory and Motor Neuropathy'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discrimination between Groups', 'timeFrame': 'Duration of the Study (9 months for Group A, one visit for Groups B and C)', 'description': 'Determine EIM device\'s ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes'}], 'secondaryOutcomes': [{'measure': 'Tracking Progression', 'timeFrame': 'Duration of Study, (9 months for Group A, one visit for Groups B and C)', 'description': 'Track EIM progression over time and determine the best summary EIM measure that could serve as an endpoint in future clinical trials and individual patient care'}, {'measure': 'Correlation with Outcome Measures', 'timeFrame': 'Duration of Study (9 months for Group A, one visit for Groups B and C)', 'description': 'Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALSFRS-R, HHD and VC.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis', 'Motor Neuron Disease', 'Charcot-Marie-Tooth Disease', 'Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular diseases, and healthy volunteers to see if the EIM device can measure disease in muscle tissue.', 'detailedDescription': 'This is a multicenter, 9-month study evaluating the effectiveness of electrical impedance myography (EIM) as a diagnostic and disease-tracking tool. In addition, the following will be studied:\n\n1. Determine EIM device\'s ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes;\n2. Track EIM progression over time and determine the best summary EIM measure that could serve as an endpoint in future clinical trials and individual patient care; and,\n3. Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALS Functional Rating Scale, Revised (ALSFRS-R), Hand-held Dynamometry (HHD) and Vital Capacity (VC) measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with ALS People diagnosed with early ALS (possible, probable, probable- laboratory supported or definite ALS according to El Escorial criteria)\n\nOther Neurological Diseases People with a diagnosis of a disease that mimics ALS\n\nHealthy Controls Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Early ALS Inclusion Criteria:\n\n* Sporadic or familial ALS (as defined by revised El Escorial criteria)\n* Onset of weakness or spasticity due to ALS ≤ 36 months prior to the Screening/Baseline Visit.\n* Slow vital capacity (SVC) ≥60% of predicted for gender, height, and age\n\nEarly ALS Exclusion Criteria:\n\n\\- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.\n\nALS Disease Mimics Inclusion Criteria:\n\n\\- Diagnosis of one of the following:\n\na. Pure Lower Motor Neuron Disease (LMND) mimics: i. Multi-focal motor neuropathy ii. Autoimmune motor neuropathy iii. Cervical or lumbosacral radiculopathies with weakness involving more than one extremity or more than a single myotome if restricted to one extremity.\n\niv. Multiple peripheral mononeuropathies with clinical weakness v. Charcot-Marie-Tooth Disease vi. Any condition that produces generalized or localized weakness without concomitant sensory symptoms, including myasthenia gravis or myopathy, that the evaluating physician deems mimics ALS.\n\nb. Pure Upper Motor Neuron Disease (UMND) mimics: i. Cervical myelopathy ii. Multiple sclerosis iii. Hereditary spastic paraparesis\n\nALS Disease Mimics Exclusion Criteria:\n\n* Diagnosis of possible, probable, probable-laboratory supported, or definite ALS\n* Presence of positive family history of ALS.\n* The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.\n\nHealthy Volunteer Inclusion Criteria:\n\n\\- Absence of a known neurological disorder.\n\nHealthy Volunteer Exclusion Criteria:\n\n* History of ALS, myopathy, neuropathy, ALS mimic disorder or other neurodegenerative disease.\n* Presence of positive family history of ALS.\n* The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.\n\n\\*Please note that this is not a complete listing on all eligibility criteria.\\*'}, 'identificationModule': {'nctId': 'NCT02011204', 'briefTitle': 'Study of Electrical Impedance Myography (EIM) in ALS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Skulpt, Inc.'}, 'officialTitle': 'Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance', 'orgStudyIdInfo': {'id': '2013P001505'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'People with ALS', 'description': 'People diagnosed with early ALS (possible, probable, probable-laboratory supported or definite ALS according to El Escorial criteria)\n\nIntervention: Electrical Impedance Myography (EIM).', 'interventionNames': ['Device: Electrical impedance myography (EIM)']}, {'label': 'Other Neurological Diseases', 'description': 'People with a diagnosis of a disease that mimics ALS', 'interventionNames': ['Device: Electrical impedance myography (EIM)']}, {'label': 'Healthy Controls', 'description': 'Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.', 'interventionNames': ['Device: Electrical impedance myography (EIM)']}], 'interventions': [{'name': 'Electrical impedance myography (EIM)', 'type': 'DEVICE', 'otherNames': ['EIM1102 device'], 'description': 'In EIM, high-frequency alternating electrical current is applied to localized areas of muscle via surface electrodes and the consequent surface voltage patterns analyzed.\n\nEIM is very sensitive to the compositional and structural elements of muscle. Data from both human subjects and animal disease models, including ALS, spinal muscular atrophy (SMA), and Duchenne muscular dystrophy (DMD), show that EIM may be sensitive to a variety of pathological states. It is anticipated that EIM will thus likely be able to assist in quantifying the severity of the disease affecting various muscle groups as well as in measuring changes in the disease over time.', 'armGroupLabels': ['Healthy Controls', 'Other Neurological Diseases', 'People with ALS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital & Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02210', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Skulpt, Inc', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Jeremy Shefner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York - Upstate Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skulpt, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}