Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT03397303
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2018-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantification of Nerve Stiffness in Neuropathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020277', 'term': 'Polyradiculoneuropathy, Chronic Inflammatory Demyelinating'}, {'id': 'D002607', 'term': 'Charcot-Marie-Tooth Disease'}], 'ancestors': [{'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015417', 'term': 'Hereditary Sensory and Motor Neuropathy'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-01-05', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nerve shear wave velocity', 'timeFrame': 'Day0', 'description': 'Ultrasound shear wave elastography will provide a measure of nerve shear wave velocity, which will be used as a surrogate of nerve stiffness.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Inflammatory Demyelinating Polyneuropathy', 'Charcot-Marie-Tooth Disease, Type IA', 'Anti-MAG Neuropathy']}, 'descriptionModule': {'briefSummary': 'This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls.', 'detailedDescription': 'The following nerve will be studied bilaterally, in a randomised order: Median, ulnar, Radial, Sciatic and Tibial.\n\nParticipants will be asked to remain relaxed during elastography measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 to 65\n* Having social insurance status\n* Having given informed consent\n* Diagnostic of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), CMT1a or Anti-MAG (peak immunoglobulin M (IGm)\\>15,000 BTU)\n\nExclusion Criteria:\n\nFor controls:\n\n* Person staying in a health or social facility\n* Person unable to understand the protocol and to respect the modalities\n* Person deprived of liberty\n* Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)\n* Participation in another biomedical research in progress\n* Diabetes, history of neuromuscular disease\n\nFor CIDP:\n\n* Person staying in a health or social facility\n* Person unable to understand the protocol and to respect the modalities\n* Person deprived of liberty\n* Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)\n* Participation in another biomedical research in progress\n* MRC score \\< 3\n\nFor Charcot-Marie-Tooth type 1 (CMT1) and anti-MAG:\n\n* Person staying in a health or social facility\n* Person unable to understand the protocol and to respect the modalities\n* Person deprived of liberty\n* Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)\n* Participation in another biomedical research in progress'}, 'identificationModule': {'nctId': 'NCT03397303', 'acronym': 'Nerf_SSI', 'briefTitle': 'Quantification of Nerve Stiffness in Neuropathies', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Quantification of Nerve Stiffness in Patients with Peripheral Neuropathies', 'orgStudyIdInfo': {'id': 'RC17_0231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with peripheral neuropathies', 'description': 'This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls.', 'interventionNames': ['Other: elastography measurements']}, {'type': 'OTHER', 'label': 'controls', 'interventionNames': ['Other: elastography measurements']}], 'interventions': [{'name': 'elastography measurements', 'type': 'OTHER', 'description': 'elastography measurements', 'armGroupLabels': ['controls', 'patients with peripheral neuropathies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Univeristy of Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Yann Pereon, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université de Nantes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}