Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-28 @ 3:53 AM
Study NCT ID:
NCT02570802
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2015-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonographic Reference Values for Peripheral Nerves in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 255}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2015-09-14', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cross-sectional area (mm2) of the C5 cervical root in children and adolescents from 2 to 18 years', 'timeFrame': 'one year', 'description': 'Cross-sectional area will be displayed as percentiles according age, weight and length'}, {'measure': 'Cross-sectional area (mm2) of the C6 cervical root in children and adolescents from 2 to 18 years', 'timeFrame': 'one year', 'description': 'Cross-sectional area will be displayed as percentiles according age, weight and length'}, {'measure': 'Cross-sectional area (mm2) of the C7 cervical root in children and adolescents from 2 to 18 years', 'timeFrame': 'one year', 'description': 'Cross-sectional area will be displayed as percentiles according age, weight and length'}, {'measure': 'Cross-sectional area (mm2) of the radial nerve in children and adolescents from 2 to 18 years', 'timeFrame': 'one year', 'description': 'Cross-sectional area will be displayed as percentiles according age, weight and length'}, {'measure': 'Cross-sectional area (mm2) of the superficial radial nerve in children and adolescents from 2 to 18 years', 'timeFrame': 'one year', 'description': 'Cross-sectional area will be displayed as percentiles according age, weight and length'}, {'measure': 'Cross-sectional area (mm2) of the peroneal nerve in children and adolescents from 2 to 18 years', 'timeFrame': 'one year', 'description': 'Cross-sectional area will be displayed as percentiles according age, weight and length'}, {'measure': 'Cross-sectional area (mm2) of the tibial nerve in children and adolescents from 2 to 18 years', 'timeFrame': 'one year', 'description': 'Cross-sectional area will be displayed as percentiles according age, weight and length'}, {'measure': 'Cross-sectional area (mm2) of the sural nerve in children and adolescents from 2 to 18 years', 'timeFrame': 'one year', 'description': 'Cross-sectional area will be displayed as percentiles according age, weight and length'}, {'measure': 'Cross-sectional area (mm2) of the vagus nerve in children and adolescents from 2 to 18 years', 'timeFrame': 'one year', 'description': 'Cross-sectional area will be displayed as percentiles according age, weight and length'}], 'secondaryOutcomes': [{'measure': 'Interrater reliability', 'timeFrame': 'one year', 'description': 'Reliability is expressed by the intraclass correlation coefficient (ICC)'}, {'measure': 'Intrarater reliability', 'timeFrame': 'one year', 'description': 'Reliability is expressed by the intraclass correlation coefficient (ICC)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Normal Values of Peripheral Nerves in Healthy Children']}, 'referencesModule': {'references': [{'pmid': '27940636', 'type': 'DERIVED', 'citation': 'Rasenack M, Decard BF, Schadelin S, Grimm A, Fischer D, Hafner P. Ultrasonographic reference values for peripheral nerves and nerve roots in the normal population of children and adolescents: study protocol for an observational-prospective trial. BMJ Open. 2016 Dec 9;6(12):e014662. doi: 10.1136/bmjopen-2016-014662.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to assess normal values of the cross-sectional area of peripheral nerves and nerve roots in children and adolescents between 2 and 18 years.', 'detailedDescription': 'This is a single center prospective clinical trial to determine standard values of the cross-sectional area of the median, ulnar, radial, peroneal, tibial, sural and vagus nerve as well as C5, C6 and C7 cervical roots in a cohort of neuromuscular unaffected children and adolescents between 2 and 18 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescents between 2 and 18 years\n* Written informed consent of the caregivers and the children/adolescents between 14 and 18 years\n\nExclusion Criteria:\n\n* Inability to meet study requirements\n* Neuromuscular disease or symptoms'}, 'identificationModule': {'nctId': 'NCT02570802', 'briefTitle': 'Ultrasonographic Reference Values for Peripheral Nerves in Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Ultrasonographic Reference Values for Peripheral Nerves and Nerve Roots in the Normal Population of Children and Adolescents', 'orgStudyIdInfo': {'id': 'Nerve US Children 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ultrasound of peripheral nerves', 'description': 'Ultrasonographic examination', 'interventionNames': ['Procedure: Ultrasonographic examination']}], 'interventions': [{'name': 'Ultrasonographic examination', 'type': 'PROCEDURE', 'armGroupLabels': ['ultrasound of peripheral nerves']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Patricia Hafner, MD', 'role': 'CONTACT', 'email': 'patricia.hafner@ukbb.ch', 'phone': '+41617042272'}, {'name': 'Maria Rasenack, MD', 'role': 'CONTACT', 'email': 'maria.rasenack@usb.ch', 'phone': '+41612652525'}], 'facility': "University of Basel, Children's Hospital", 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Patricia Hafner, MD', 'role': 'CONTACT', 'email': 'patricia.hafner@ukbb.ch', 'phone': '+41617042272'}, {'name': 'Maria Rasenack, MD', 'role': 'CONTACT', 'email': 'maria.rasenack@usb.ch', 'phone': '+41612652525'}], 'overallOfficials': [{'name': 'Dirk Fischer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University of Basel, Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': "University Children's Hospital Basel", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}