Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-02 @ 2:35 AM
Study NCT ID:
NCT05360303
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2022-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electromyography in Thoracic Outlet Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013901', 'term': 'Thoracic Outlet Syndrome'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2022-04-29', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the presence of ENMG abnormality and in particular on the medial cutaneous nerve of the forearm of patients with a clinical diagnosis of TOS', 'timeFrame': '0 Month', 'description': 'Conduction abnormality of the medial cutaneous nerve of the forearm'}], 'secondaryOutcomes': [{'measure': 'Evaluation of ENMG changes following rehabilitation treatment of patients', 'timeFrame': '1 Month', 'description': 'evolution of electrophysiological changes following treatment'}, {'measure': 'Evaluation of ENMG changes following rehabilitation treatment of patients', 'timeFrame': '1 Month', 'description': 'evolution of the Visual Analog Score for pain (scale from 0 to 10 ; 10 being the worst outcome)'}, {'measure': 'Evaluation of ENMG changes following rehabilitation treatment of patients', 'timeFrame': '1 Month', 'description': 'evolution of the Quick Disabilities of the Arm, Shoulder and Hand Score (scale from 0 to 100 ; 100 being the worst outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracic outlet syndrome', 'electromyography', 'neurogenic', 'rehabilitation', 'diagnosis'], 'conditions': ['Thoracic Outlet Syndrome']}, 'descriptionModule': {'briefSummary': 'Record the ENMG data carried out systematically in patients treated by rehabilitation for thoracic outlet syndrome in order to assess their characteristics and judge the relevance of these data in the context of the diagnosis and their possible modifications following the rehabilitation treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a thoracic outlet syndrome who will be included during their usual rehabilitation management. They will benefit from the usual Electromyography of stimulodetection with surface electrodes at the beginning of the management. The same examination will be performed at the end of the treatment to evaluate the impact of the rehabilitation on the electrophysiological results and to orientate, if necessary, towards a potential surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inpatient rehabilitation for thoracic outlet syndrome\n* Patients' agreement\n\nExclusion Criteria:\n\n* \\< 18 years old\n* Not able to consent\n* Pregnancy\n* Musculoskeletal disorders of the upper limbs\n* Acute cardiac, pulmonary, metabolic or neurological diseases"}, 'identificationModule': {'nctId': 'NCT05360303', 'acronym': 'ENMG-AFC', 'briefTitle': 'Electromyography in Thoracic Outlet Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Interest of Electroneuromyography in the Diagnosis of Thoracic Outlet Syndrome', 'orgStudyIdInfo': {'id': 'RC22_0229'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trial population', 'description': 'No Intervention but evaluation of the electroneuromyography at the M1 visit for patients with a clinical diagnostic of thoracic outlet syndrome.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'Department of Physical Medicine and Locomotive Rehabilitation (Nantes University Hospital)', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}