Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-02-17 @ 4:15 PM
Study NCT ID:
NCT02159612
Status:
COMPLETED
Last Update Posted:
2015-05-14
First Post:
2014-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020391', 'term': 'Muscular Dystrophy, Facioscapulohumeral'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-13', 'studyFirstSubmitDate': '2014-06-06', 'studyFirstSubmitQcDate': '2014-06-06', 'lastUpdatePostDateStruct': {'date': '2015-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fat infiltration', 'timeFrame': '1 year', 'description': 'Change in the distribution of fat infiltration in back, thigh and calves muscles seen at the MRI images.'}], 'secondaryOutcomes': [{'measure': 'Muscle structure', 'timeFrame': '1 year', 'description': 'Muscle structure is evaluated with a four-point semi-quantitative visual scale. Two observers evaluate images independently. Changes in evaluation between 1st and 2nd scan are the outcome measure.'}, {'measure': 'Muscle strength', 'timeFrame': '1 year', 'description': 'Changes in muscle strength between 1st. and 2nd MRI-scan.'}, {'measure': 'Back pain', 'timeFrame': '1 year', 'description': 'Changes in self-assessed back-pain between 1st. and 2nd scan.'}, {'measure': 'Muscle function', 'timeFrame': '1 year', 'description': 'Changes in muscle function between 1st and 2nd MRI-scan, measured by a 6 minute walk test, a 14-step-stair test and a 5-times-sit-to-stand-test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FSHD', 'MRI', 'Disease progression'], 'conditions': ['FSHD - Facioscapulohumeral Muscular Dystrophy']}, 'referencesModule': {'references': [{'pmid': '32611642', 'type': 'DERIVED', 'citation': 'Dahlqvist JR, Poulsen NS, Ostergaard ST, Fornander F, de Stricker Borch J, Danielsen ER, Thomsen C, Vissing J. Evaluation of inflammatory lesions over 2 years in facioscapulohumeral muscular dystrophy. Neurology. 2020 Sep 1;95(9):e1211-e1221. doi: 10.1212/WNL.0000000000010155. Epub 2020 Jul 1.'}], 'seeAlsoLinks': [{'url': 'http://neuromuscular.dk', 'label': 'The home-page of neuromuscular research units department in Copenhagen, Denmark'}]}, 'descriptionModule': {'briefSummary': 'An investigation of disease progression in adult danish patients with facioscapulohumeral muscular dystrophy. The disease progression is followed for a year with two test-days, including functional muscle tests and a MRI scan of muscles in the back and legs.', 'detailedDescription': 'A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan to describe the relation between backpain and disease affection in back muscles. After one year they are re-invited to perform another MRI scan to follow the disease progression.\n\nThe MRI scan is done to measure the quantity and quality of the muscles in the back, thigh and calf. Further, investigators investigate the muscle function by measuring of muscle strength in legs and in the back together with three functional tests. A walking test (6MWT), a stair test (14SST), and a chair test (5-TSTST). Self-assessment of back pain is measured by a standardized questionnaire about backpain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Persons in Denmark diagnosed with Facioscapulohumeral muscular dystrophy is invited to the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with FSHD type 1\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Patients with claustrophobia.\n* Patients with implanted metallic parts in the body.'}, 'identificationModule': {'nctId': 'NCT02159612', 'acronym': 'FSHD', 'briefTitle': '1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Disease Progression in Facioscapulohumeral Muscular Dystrophy - 1 Year MRI Follow-up', 'orgStudyIdInfo': {'id': 'H-3-2012-163 (fsh)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FSHD', 'description': 'A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan.', 'interventionNames': ['Other: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'OTHER', 'description': 'MRI scan of muscles in the back and legs. Including T1, DIXON and STIR images.', 'armGroupLabels': ['FSHD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Neuromuscular Research Unit, Department of Neurology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grete Andersen, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Grete Andersen, MD', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}