Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT05553457
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2022-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MyHand-SCI: an Active Hand Orthosis for Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D011782', 'term': 'Quadriplegia'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2022-09-21', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System Usability Scale', 'timeFrame': 'Up to 2 years at study completion', 'description': 'The System Usability Scale (SUS) is a reliable tool for measuring the usability of products, including medical devices. It consists of a 10 item questionnaire with five response options (Strongly agree to Strongly disagree).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Spinal Cord Injuries', 'Tetraplegia', 'Rehabilitation', 'Robotics', 'Assistive Technology', 'Wearable Devices'], 'conditions': ['Spinal Cord Injuries', 'Tetraplegia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals with C6-C7 spinal cord injury.', 'detailedDescription': 'The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals with C6-C7 spinal cord injury. This is a non-randomized exploratory study to determine feasibility of device use, provide user feedback on device features and function to allow further refinement of the device, and assess the utility and responsiveness of several clinical outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with C6-C7 spinal cord injury, at least 6-months post-injury with impaired upper limb function\n* Substantially reduced motor control and strength below the level of their SCI with regard to hand and finger function\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Fixed upper limb contractures that limit functional use of the hand and arm or ability to use the device\n* Severe spasticity (modified Ashworth \\>2) at elbow, wrist, or fingers\n* Any open wounds or unusual skin fragility\n* Persistent severe pain in their upper limb'}, 'identificationModule': {'nctId': 'NCT05553457', 'briefTitle': 'MyHand-SCI: an Active Hand Orthosis for Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'MyHand-SCI: a Wearable Robotic Hand Orthosis for C6-C7 Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'AAAU2339'}, 'secondaryIdInfos': [{'id': 'R01NS115652', 'link': 'https://reporter.nih.gov/quickSearch/R01NS115652', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MyHand-SCI Device Testing', 'description': 'Subjects will attend 1-20 sessions (of approximately 90 mins) to trial a variety of the MyHand-SCI device controls and/or components. Participants will practice various grasp and release activities with the device', 'interventionNames': ['Device: Testing of MyHand-SCI Device']}], 'interventions': [{'name': 'Testing of MyHand-SCI Device', 'type': 'DEVICE', 'description': 'Subjects will attend 1-20 sessions (approximately 90 minutes) to trial the MyHand-SCI device, including a variety of controls and components.', 'armGroupLabels': ['MyHand-SCI Device Testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Winterbottom, MS', 'role': 'CONTACT', 'email': 'lbw2136@cumc.columbia.edu', 'phone': '212-305-6722'}], 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Lauren Winterbottom, MS', 'role': 'CONTACT', 'email': 'lbw2136@cumc.columbia.edu', 'phone': '212-305-6722'}, {'name': 'Joel Stein, MD', 'role': 'CONTACT', 'phone': '212-305-4818'}], 'overallOfficials': [{'name': 'Joel Stein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair of the Department of Rehabilitation and Regenerative Medicine', 'investigatorFullName': 'Joel Stein, MD', 'investigatorAffiliation': 'Columbia University'}}}}