Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-05 @ 6:04 PM
Study NCT ID:
NCT04430218
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2020-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Interfaces in Amputees for Sensorimotor Integration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assessments will be analyzed by a blinded assessor.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': "This study is designed as a randomized clinical trial in a small population of subjects to answer the primary question of whether use of a sensory-enabled, high degree-of-freedom (SE-ihDOF) prosthesis with the iSens system improves the subject's quality of life compared to use of their prescribed state-of-art (SOA) prosthesis"}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2032-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Experience Measure', 'timeFrame': '9 months post implant', 'description': 'Consists of 49 items and consists of five subscales, measuring Self-efficacy, Embodiment, Body image, Prosthesis Efficiency, and Social Touch. Each scale is scored individually, and a higher score indicates a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Modified Box and Blocks', 'timeFrame': '9 months post implant', 'description': 'Measuring the change in numbers of blocks moved during a timed test.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Sensory Feedback', 'Advanced Control', 'Sensorimotor feedback', 'Prostheses and implants'], 'conditions': ['Upper Extremity Amputee']}, 'referencesModule': {'references': [{'pmid': '41297066', 'type': 'DERIVED', 'citation': 'Cady SR, Lambrecht JM, Tyler DJ. Enhanced sensory perception and myoelectric control with high channel count implanted sensorimotor systems. J Neural Eng. 2025 Nov 26. doi: 10.1088/1741-2552/ae24ae. Online ahead of print.'}, {'pmid': '40269935', 'type': 'DERIVED', 'citation': 'Cady SR, Lambrecht JM, Dsouza KT, Dunning JL, Anderson JR, Malone KJ, Chepla KJ, Graczyk EL, Tyler DJ. First-in-human implementation of a bidirectional somatosensory neuroprosthetic system with wireless communication. J Neuroeng Rehabil. 2025 Apr 23;22(1):90. doi: 10.1186/s12984-025-01613-z.'}, {'pmid': '38861967', 'type': 'DERIVED', 'citation': 'Lambrecht JM, Cady SR, Peterson EJ, Dunning JL, Dinsmoor DA, Pape F, Graczyk EL, Tyler DJ. A distributed, high-channel-count, implanted bidirectional system for restoration of somatosensation and myoelectric control. J Neural Eng. 2024 Jun 21;21(3). doi: 10.1088/1741-2552/ad56c9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.', 'detailedDescription': 'The study involves a surgical implant of cuff electrodes on the residual nerves in the amputated limb, and muscle recording electrodes in muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is touching.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 or greater\n* Acquired upper limb amputation\n* Unilateral or bilateral amputation, Above or below elbow\n* At least 6 months since time of amputation\n* Current user of a myoelectric prosthesis or prescribed to use one\n* Viable target nerves in the upper extremity \\*\n* Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities\n\nExclusion Criteria:\n\n* A contraindication preventing surgery\n* Uncontrolled diabetes\n* Chronic skin ulcerations\n* History of poor wound healing without specific cause\n* History of uncontrolled infection without specific cause\n* Active infection\n* Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study\n* Inability to speak English\n* Expectation that MRI will be required at any point for duration of study or while device is implanted.\n* Arthritis in the area of implant\n* Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators)\n* Presence of auto immune diseases, or conditions requiring immunosuppression.'}, 'identificationModule': {'nctId': 'NCT04430218', 'acronym': 'iSens', 'briefTitle': 'Peripheral Interfaces in Amputees for Sensorimotor Integration', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Peripheral Interfaces in Amputees for Sensorimotor Integration', 'orgStudyIdInfo': {'id': 'A3355-R'}, 'secondaryIdInfos': [{'id': 'RX003355-01', 'type': 'OTHER_GRANT', 'domain': 'VA RR&D'}, {'id': 'HT94252510204', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense (CDMRP)'}, {'id': '1612632', 'type': 'OTHER', 'domain': 'IRBnet'}, {'id': 'CDMRP-PR241366', 'type': 'OTHER', 'domain': 'CDMRP-eBRAP Log number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iSens', 'description': '3 months trial with the iSens system', 'interventionNames': ['Device: iSens']}, {'type': 'NO_INTERVENTION', 'label': 'State of the Art Prosthesis', 'description': '3 months trial with their own prosthesis.'}], 'interventions': [{'name': 'iSens', 'type': 'DEVICE', 'description': 'The study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching.', 'armGroupLabels': ['iSens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-1702', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Holly B Henry', 'role': 'CONTACT', 'email': 'holly.henry@va.gov', 'phone': '216-791-3800', 'phoneExt': '64657'}, {'name': 'Neal S Peachey, PhD', 'role': 'CONTACT', 'email': 'neal.peachey@va.gov', 'phone': '(216) 421-3221'}, {'name': 'Dustin J. Tyler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Louis Stokes VA Medical Center, Cleveland, OH', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Dustin J Tyler, PhD', 'role': 'CONTACT', 'email': 'dustin.tyler@va.gov', 'phone': '(216) 791-3800'}, {'name': 'Melissa S Schmitt', 'role': 'CONTACT', 'email': 'Melissa.Schmitt@va.gov', 'phone': '(216) 791-3800', 'phoneExt': '63801'}], 'overallOfficials': [{'name': 'Dustin J. Tyler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Louis Stokes VA Medical Center, Cleveland, OH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Deidentified data will be uploaded to a data repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'Congressionally Directed Medical Research Programs', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}