Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT03983720
Status:
TERMINATED
Last Update Posted:
2023-11-02
First Post:
2019-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'whyStopped': 'low inclusion rates', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2019-06-07', 'studyFirstSubmitQcDate': '2019-06-11', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Voluntary maximum contraction', 'timeFrame': 'Day : 30', 'description': 'Comparison the percentage of decrease in voluntary maximum contraction reported after the fatiguing task. Measured by an instrumented measuring pedal (PowerForce pedal, Model PF1.0.0.0, Radlabor GmbH, Freiburg, Germany)'}], 'secondaryOutcomes': [{'measure': 'Neuromuscular function during the dynamic strenuous exercise', 'timeFrame': 'Day : 30', 'description': 'Cortical activity by transcranial magnetic stimulation, evaluated by recording of the evoked motor potentials\n\n.'}, {'measure': 'Muscle oxygen extraction capacity', 'timeFrame': 'Day : 30', 'description': 'Measured by near-infrared spectroscopy (NIRS)'}, {'measure': 'Anemia', 'timeFrame': 'Day : 30', 'description': 'Measured by blood count in blood sample'}, {'measure': 'Inflammation', 'timeFrame': 'Day : 30', 'description': 'Measured by C-reactiv protein in blood sample'}, {'measure': 'VO2 max', 'timeFrame': 'Day : 30', 'description': 'Measured by effort test'}, {'measure': 'Heart rate', 'timeFrame': 'Day : 30', 'description': 'Measured by heart rate monitor'}, {'measure': 'Cognitive fatigue', 'timeFrame': 'Day : 30', 'description': 'Measured by Symbol Digit Modalities Test'}, {'measure': 'Perceived fatigue', 'timeFrame': 'Day : 30', 'description': 'Measured by Borg scale'}, {'measure': 'Thermoregulation', 'timeFrame': 'Day : 30', 'description': 'Measured by digestible thermometric pill (e-celcius Performance)'}, {'measure': 'Sleep quality', 'timeFrame': 'Day : 30', 'description': 'Measured by actigraphy'}, {'measure': 'Muscle volume', 'timeFrame': 'Day : 30', 'description': 'Measured by Magnetic Resonance Imaging'}, {'measure': 'Metabolic fatigue', 'timeFrame': 'Day : 30', 'description': 'Measured by a Phosphorus 31 Nuclear Magnetic Resonance test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep assessment', 'Neuromuscular Fatigability', 'Multiple sclerosis', 'Chronic fatigue'], 'conditions': ['Sclerosis, Multiple']}, 'descriptionModule': {'briefSummary': 'Chronic fatigue is the most common and debilitating symptom in multiple sclerosis patients. This chronic fatigue affects their quality of life by decreasing their capacity to perform simple tasks of daily life.\n\nThe aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in this feeling of chronic fatigue. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology will allow to optimize rehabilitation treatments to decrease the apparition/persistence of chronic fatigue and in fine improve quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Patients:\n\n* Aged ≥ 18 and ≤ 70 years\n* Men or women\n* With multiple sclerosis since 2 and 25 years\n* Affiliates or beneficiaries of social security scheme\n* Signed consent\n\nFor Healthy volunteers:\n\n* Aged ≥ 18 and ≤ 70 years\n* Men or women\n* Matched in accordance with age, sex and level of physical activity\n\nExclusion Criteria:\n\nFor Patients and Healthy volunteers:\n\n* High heart rate resting\n* Blood pressure \\> 144/94 mmHg\n* Recent adjustment of drug or drug can have an impact on fatigue or stimulant for fatigue\n* Taking neuroactive substances that can alter corticospinal excitability\n* Contraindication at application magnetic field\n* Contraindication at Magnetic Resonance Imaging (MRI)\n* Currently participating in a structured exercise program\n* Pregnant\n\nFor Patients only:\n\n* Spasticity or cerebellar ataxia\n* Abnormal range of motion (toe and/or ankle)\n* Musculoskeletal injuries that impedes pedaling\n* Appearance of symptoms of multiple sclerosis in the 90 days preceding the study\n\nFor Healthy volunteers:\n\n\\- Neurological diseases, cardiovascular, musculoskeletal'}, 'identificationModule': {'nctId': 'NCT03983720', 'acronym': 'FatSEP', 'briefTitle': 'Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?', 'orgStudyIdInfo': {'id': '19CH030'}, 'secondaryIdInfos': [{'id': '2019-A00427-50', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with multiple sclerosis and lowly fatigued', 'description': 'Patient with multiple sclerosis and lowly fatigued will be included.\n\nThey will have:\n\nVisit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue', 'interventionNames': ['Other: Evaluation of degree chronic fatigue.', 'Other: Questionnaires', 'Biological: Blood sample', 'Other: Cardiopulmonary evaluation', 'Device: Capacity of muscular oxygen extraction', 'Device: Sleep assessment', 'Device: Metabolic fatigue', 'Other: Neuromuscular evaluation']}, {'type': 'EXPERIMENTAL', 'label': 'Patient with multiple sclerosis and highly fatigued', 'description': 'Patient with multiple sclerosis and highly fatigued will be included. They will have:\n\nVisit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue', 'interventionNames': ['Other: Evaluation of degree chronic fatigue.', 'Other: Questionnaires', 'Biological: Blood sample', 'Other: Cardiopulmonary evaluation', 'Device: Capacity of muscular oxygen extraction', 'Device: Sleep assessment', 'Device: Metabolic fatigue', 'Other: Neuromuscular evaluation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy subjects', 'description': 'Healthy subjects will be included. They will have:\n\nVisit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue', 'interventionNames': ['Other: Questionnaires', 'Biological: Blood sample', 'Other: Cardiopulmonary evaluation', 'Device: Capacity of muscular oxygen extraction', 'Device: Sleep assessment', 'Device: Metabolic fatigue', 'Other: Neuromuscular evaluation']}], 'interventions': [{'name': 'Evaluation of degree chronic fatigue.', 'type': 'OTHER', 'description': 'Evaluation of degree chronic fatigue with the results of survey Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS). This result will allow to divide patients in groups : lowly fatigued and highly fatigued.', 'armGroupLabels': ['Patient with multiple sclerosis and highly fatigued', 'Patient with multiple sclerosis and lowly fatigued']}, {'name': 'Questionnaires', 'type': 'OTHER', 'description': '* Fatigue Severity Scale (FSS)\n* Modified Fatigue Impact Scale (MFIS)\n* Godin Leisure-Time Exercise Questionnaire (GLTEQ)\n* Scale of life quality of multiple sclerosis (SEP-59)\n* Center for Epidemiologic Studies Depression (CES-D)\n* Pittsburgh Sleep Quality Index (PSQ-I)', 'armGroupLabels': ['Healthy subjects', 'Patient with multiple sclerosis and highly fatigued', 'Patient with multiple sclerosis and lowly fatigued']}, {'name': 'Blood sample', 'type': 'BIOLOGICAL', 'description': 'Blood sample will be realized to evaluate anemia and inflammations.', 'armGroupLabels': ['Healthy subjects', 'Patient with multiple sclerosis and highly fatigued', 'Patient with multiple sclerosis and lowly fatigued']}, {'name': 'Cardiopulmonary evaluation', 'type': 'OTHER', 'description': 'Cardiopulmonary evaluation will be realized with a cycle ergometer.', 'armGroupLabels': ['Healthy subjects', 'Patient with multiple sclerosis and highly fatigued', 'Patient with multiple sclerosis and lowly fatigued']}, {'name': 'Capacity of muscular oxygen extraction', 'type': 'DEVICE', 'description': 'Measure the capacity of muscular oxygen extraction with a cycle ergometer.', 'armGroupLabels': ['Healthy subjects', 'Patient with multiple sclerosis and highly fatigued', 'Patient with multiple sclerosis and lowly fatigued']}, {'name': 'Sleep assessment', 'type': 'DEVICE', 'description': 'Sleep assessment will be measured by actigraphy during 15 days.', 'armGroupLabels': ['Healthy subjects', 'Patient with multiple sclerosis and highly fatigued', 'Patient with multiple sclerosis and lowly fatigued']}, {'name': 'Metabolic fatigue', 'type': 'DEVICE', 'description': 'Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).', 'armGroupLabels': ['Healthy subjects', 'Patient with multiple sclerosis and highly fatigued', 'Patient with multiple sclerosis and lowly fatigued']}, {'name': 'Neuromuscular evaluation', 'type': 'OTHER', 'description': 'Neuromuscular evaluation will be measured by the composite of the results of:\n\n* Fatigue test\n* Measure of voluntary isometric force\n* Surface electromyography\n* Peripheral nerve stimulation\n* Transcranial Magnetic Stimulation (TMS)\n* Perceived fatigue\n* Cognitive fatigue\n* Thermoregulation', 'armGroupLabels': ['Healthy subjects', 'Patient with multiple sclerosis and highly fatigued', 'Patient with multiple sclerosis and lowly fatigued']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Jean-Philippe CAMDESSANCHE, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU DE SAINT ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}