Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-30 @ 2:44 AM
Study NCT ID:
NCT04369092
Status:
COMPLETED
Last Update Posted:
2020-04-30
First Post:
2020-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-27', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myotonometric Measurement', 'timeFrame': 'through study completion, average one hour', 'description': "MyotonPro® device was used to measure muscles' viscoelastic parameters. The device is valid and reliable for measuring viscoelastic parameters (5, 6). Tonus, stiffness, elasticity of the muscles were recorded. Three measurements were bilaterally taken for each muscle. For each muscle, the average values of stiffness, tone and elasticity were retained as the main MyotonPRO outcomes. Myotonometric measurements were carried out for Masseter, Orbicularis Oris and Sternocleidomastoid (SKM) in supine position."}], 'secondaryOutcomes': [{'measure': 'Eating Assessment Tool', 'timeFrame': 'through study completion, average one hour', 'description': "Eating Assessment Tool was used to assess symptom of dysphagia. EAT-10 consisted of ten items, each of items was scored from 0 to 4. As the score increases, the patient's symptoms become deterioration."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis', 'Dysphagia', 'Swallowing Disorder', 'Deglutition Disorders', 'Muscle Tonus']}, 'descriptionModule': {'briefSummary': "Multiple Sclerosis is a chronic inflammatory autoimmune neurological disease characterized by the destruction of myelin in the central nervous system, grey matter and axonal loss. The prevalence of neurogenic dysphagia in this group of patients is estimated to be more than 30%. The aim of this study was investigating of Masseter, Orbicularis Oris, Sternocleidomastoid muscles' viscoelastic properties in MS patients with and without swallowing problems.", 'detailedDescription': "The aim of this study was investigating of Masseter, Orbicularis Oris, Sternocleidomastoid muscles' viscoelastic properties in MS patients with and without swallowing problems. It carried out that myotonometric assessment of muscles in multiple sclerosis patients with dysphagia and comparison of these properties."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. being diagnosed with Mc Donald's Multiple sclerosis (MS) in accordance with 2010 criteria,\n2. being between the ages of 18-45.\n\nExclusion Criteria:\n\n1. having psychological, orthopedic and other neurological disorders,\n2. pregnancy,\n3. having had an attack in the last 3 months,\n4. application of botulinum toxin in the last 6 months."}, 'identificationModule': {'nctId': 'NCT04369092', 'briefTitle': 'Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'Myotonometric Assessment of Muscles in Multiple Sclerosis Patients With Dysphagia', 'orgStudyIdInfo': {'id': '2019/105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'without swallowing problem', 'description': 'patients without swallowing problem', 'interventionNames': ['Other: DYMUS']}, {'type': 'OTHER', 'label': 'mild swallowing problem', 'description': 'patients with mild swallowing problem', 'interventionNames': ['Other: DYMUS']}, {'type': 'OTHER', 'label': 'severe swallowing problem', 'description': 'patients with severe swallowing problem', 'interventionNames': ['Other: DYMUS']}], 'interventions': [{'name': 'DYMUS', 'type': 'OTHER', 'otherNames': ['evaluating oropharyngeal dysphagia'], 'description': 'DYsphagia in MUltiple Sclerosis (DYMUS) that was questionnare and Eating Assessment Tool (EAT-10) were used for assess swallowing problem. All individuals were classified according to DYMUS. The DYMUS Score was 1 or 2 was taken as mild swallowing problems, 3 or more was taken as severe swallowing problems. Patients were divided into three groups; first group that include patients without swallowing problems, second group that include patients with mild swallowing problems, third group that include severe swallowing problems.', 'armGroupLabels': ['mild swallowing problem', 'severe swallowing problem', 'without swallowing problem']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Hasan Kalyoncu University', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tuba Maden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, clinical research', 'investigatorFullName': 'Tuba Maden', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}