Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT00606918
Status:
COMPLETED
Last Update Posted:
2011-05-12
First Post:
2008-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a New Device to Measure Neuromuscular Disease Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-11', 'studyFirstSubmitDate': '2008-01-22', 'studyFirstSubmitQcDate': '2008-02-04', 'lastUpdatePostDateStruct': {'date': '2011-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'isometric strength measures', 'timeFrame': 'cross sectional'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Strength testing', 'Disease progression', 'ALS', 'Healthy Adults'], 'conditions': ['Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders']}, 'descriptionModule': {'briefSummary': 'There is a great need for the development of sensitive outcomes that allow experimental drugs to be tested in human subjects more efficiently. If we could more precisely measure whether an experimental drug slows the progression of ALS or other neuromuscular diseases, this would allow more drugs to be tested quicker and at less expense. We have developed a new device that accurately measures isometric strength called: Accurate Test of Limb Isometric Strength (ATLIS). This device was designed to be portable, quick, and easy to use, while generating accurate and reliable, interval level data. This study will enable us to test the reliability and validity of ATLIS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with ALS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects must be at least 18 years old and able to provide informed consent\n* All subjects have no health conditions that limit their ability to safely exert maximal force using the muscles in their arms and legs.\n* Subjects with a diagnosis of laboratory supported probable, probable or definite ALS according to the World Federation of Neurology El Escorial, as determined by their referring neurologist at MGH.\n* All subjects must be able to speak and understand English.\n\nExclusion Criteria:\n\n* Presence of significant arthritis, orthopedic conditions, or cardio-pulmonary conditions or other medical conditions that may limit the ability to maximally exert force safely.'}, 'identificationModule': {'nctId': 'NCT00606918', 'acronym': 'ATLIS', 'briefTitle': 'Validation of a New Device to Measure Neuromuscular Disease Progression', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Validation of a New Device to Measure Neuromuscular Disease Progression', 'orgStudyIdInfo': {'id': 'MDA-4343'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Individuals with ALS'}, {'label': '2', 'description': 'Healthy Adults'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital - East', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}], 'overallOfficials': [{'name': 'Patricia L. Andres, MS, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Patricia L. Andres', 'oldOrganization': 'Massachusetts General Hospital'}}}}