Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-28 @ 12:37 AM
Study NCT ID:
NCT01785550
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2013-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromuscular Ultrasound in ALS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2013-02-06', 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormalities at onset: Ultrasound vs. Electromyography', 'timeFrame': '1 year', 'description': "Ultrasound measures will be compared to electromyography measures at the patient's initial assessment. The number of abnormal muscles will be counted using each technique and analyzed to determine if one test is superior."}], 'secondaryOutcomes': [{'measure': 'Ultrasound Predicting Outcome at 1 year', 'timeFrame': '1.5 years', 'description': 'The initial ultrasound measures and patient outcomes, as measured by standard validated scales, will be assessed at periodic intervals for one year. Analysis will be performed to determine if ultrasound measures can predict the clinical course.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['ALS']}, 'descriptionModule': {'briefSummary': 'Amyotrophic Lateral Sclerosis (ALS) is a progressive fatal neurodegenerative disease affecting motor neurons. Early diagnosis is essential for the success of clinical trials and objective biomarkers are needed for monitoring disease progression. Nerve and muscle ultrasound may provide this information.\n\nThis study will collect pilot data to evaluate the value of muscle and nerve ultrasound to identify and monitor disease progression in ALS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients referred to the electromyography laboratory for ALS.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects referred to the electromyography laboratory for ALS.\n\nExclusion Criteria:\n\n* Patients with known comorbid myopathy or neuropathy will be excluded from the study.\n* Patients unable to provide their own consent will be excluded.'}, 'identificationModule': {'nctId': 'NCT01785550', 'briefTitle': 'Neuromuscular Ultrasound in ALS', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Ultrasonography in Amyotrophic Lateral Sclerosis as a Predictor of Disease Progression and Tool in Diagnosis: a Pilot Study', 'orgStudyIdInfo': {'id': 'Pro00042025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'No intervention to be performed.'}, {'label': 'Ultrasound Group', 'description': 'All will receive nerve and muscle ultrasound.', 'interventionNames': ['Other: Ultrasound of nerve and muscle']}], 'interventions': [{'name': 'Ultrasound of nerve and muscle', 'type': 'OTHER', 'description': 'Ultrasound of 6 muscles and 2 nerves will be performed.', 'armGroupLabels': ['Ultrasound Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}