Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-13 @ 7:47 AM
Study NCT ID:
NCT06458751
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2024-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrophysiological Study of Berrettini Anastomosis
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': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-06-12', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'analysis of the sensory potential (UV amplitude in MSEC) recorded on both sides of the IV finger of the hand by stimulation of the median nerve and the ulnar one', 'timeFrame': 'immediately after the procedure'}, {'measure': 'analysis of the sensory potential ( latency in MSEC) recorded on both sides of the IV finger of the hand by stimulation of the median nerve and the ulnar one', 'timeFrame': 'immediately after the procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Electrophysiologic Study', 'Hand Anastomosis']}, 'descriptionModule': {'briefSummary': 'The common opinion that sensory supply of digit 5 (D5) and medial half of digit 4 (D4) of the hand is by ulnar nerve, while the lateral half of D4 and the remaining digits is by median nerve is an oversimplification of a complex topic. Indeed, the literature demonstrated that both the median and ulnar nerves display a number of deviations to the traditionally taught branching patterns.\n\nThe aim of our study was to investigate the physiological role of median and ulnar nerves in the sensory supply of D4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '24 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 24-60 years\n* male and female\n* under informed consent\n* no history of previous neuromuscular disease and no abnormalities on neurological examination\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06458751', 'briefTitle': 'Electrophysiological Study of Berrettini Anastomosis', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Electrophysiological Study of Berrettini Anastomosis', 'orgStudyIdInfo': {'id': 'MANOSENS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '30 healthy subjects with no history of neuromuscular disease', 'description': '30 healthy subjects with no history of previous neuromuscular disease and no abnormalities on neurological examination', 'interventionNames': ['Other: electrophysiological study', 'Device: electromyograph']}], 'interventions': [{'name': 'electrophysiological study', 'type': 'OTHER', 'description': 'Antidromic sensory nerve conduction studies of median and ulnar nerves will be performed on both hands of 30 healthy subjects with no history of previous neuromuscular disease and no abnormalities on neurological examination., by using surface electrical stimulation at wrist and surface digital recording electrodes on both sides of D4.', 'armGroupLabels': ['30 healthy subjects with no history of neuromuscular disease']}, {'name': 'electromyograph', 'type': 'DEVICE', 'description': 'surface electrical stimulation at wrist and surface digital recording electrodes on both sides of D4.', 'armGroupLabels': ['30 healthy subjects with no history of neuromuscular disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': "Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Alberto Cappellari', 'investigatorAffiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}}}}