Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
Study NCT ID:
NCT02034461
Status:
TERMINATED
Last Update Posted:
2022-07-07
First Post:
2013-05-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Micro-Electrodes Implanted in a Human Nerve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'This device feasibility study was using a microelectrode array device to determine\n\nviability of the product. Design and operating specification of the device were established. A new IDE\n\ntrial has been initiated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-01', 'studyFirstSubmitDate': '2013-05-03', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device feasibility to collect data from peripheral nerves, and will consist of action potentials (mV) arising from the axons surrounding the tip of each electrode.', 'timeFrame': 'Up to 4 Week Follow-up', 'description': 'Device feasibility evaluation to confirm design and operating specifications of the device to collect action potentials from peripheral nerves.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Micro-Electrodes', 'Peripheral Nerve Injury', 'Amputation', 'Spinal Cord Injury'], 'conditions': ['Amputations', 'Peripheral Nerve Injury', 'Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'The main objective of the intervention in the study is devise feasibility using high-count microelectrode arrays implanted into peripheral nerves of patients with limb amputations or peripheral nerve injury. These microelectrodes will be custom-made and are not available for commercial distribution. The investigators hypothesize that recording neural signals from a large number of microelectrodes will provide selective motor information in high enough numbers to allow control over future artificial devices with many moving parts, i.e. artificial limbs with shoulder, elbow, wrist, and/or individual fingers that move. These studies will also investigate to what extent microstimulation of nerve fibers can provide sensory feedback from a prosthetic limb.\n\nThe investigators will also conduct up to three acute surgeries where a Utah slanted Electrode Array (USEA) will be implanted in volunteers who are about to undergo limb amputations. These acute implantations will provide Dr. Hutchinson with human surgical experience in implanting USEAs and evaluating the containment system we will be using to immobilize the implanted USEA in the nerve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years of age and less than 65 years of age\n* amputations\n* peripheral nerve injury\n* twelve participants for the 30 day implantation/physiological experimentation study\n* three participants for the acute surgical implantation part of the study\n\nExclusion Criteria:\n\n* incarceration\n* pregnancy\n* inability to consent\n* psychiatric comorbidity\n* increase the risk of adverse effects of general anesthesia'}, 'identificationModule': {'nctId': 'NCT02034461', 'briefTitle': 'Micro-Electrodes Implanted in a Human Nerve', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Sensory Feedback Useful for Controlling a Prosthetic Device?', 'orgStudyIdInfo': {'id': '55621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute surgical implantation', 'description': 'The investigators will conduct three acute surgeries where a Utah slanted Electrode Array (USEA) will be implanted in volunteers who are about to undergo limb amputations. These acute implantations will provide the PI with human surgical experience in implanting USEAs and evaluating the containment system the investigators will be using to immobilize the implanted USEA in the nerve.', 'interventionNames': ['Device: Utah Slanted Electrode Array']}, {'type': 'EXPERIMENTAL', 'label': 'Implantation of a Utah Electrode Array', 'description': 'The arm which has been amputated or has peripheral nerve trauma. Intervention include insertion of the Utah Slanted Electrode Arrays which will interact with nerve endings in order to gain knowledge about device feasibility and nerve stimulation.', 'interventionNames': ['Device: Utah Slanted Electrode Array']}], 'interventions': [{'name': 'Utah Slanted Electrode Array', 'type': 'DEVICE', 'description': 'Microelectrode slanted arrays with a large number of electrodes will be surgically implanted into peripheral nerves of patients with limb amputations or peripheral nerve trauma.', 'armGroupLabels': ['Acute surgical implantation', 'Implantation of a Utah Electrode Array']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'The University Orthopaedic Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Douglas Hutchinson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopedic Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Douglas Hutchinson', 'investigatorAffiliation': 'University of Utah'}}}}