Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-26 @ 1:01 AM
Study NCT ID:
NCT07299734
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility and Safety of a Combined Augmented Reality and Functional Electrical Stimulation System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Graded Redefined Assessment of Strength, Sensation and Prehension', 'timeFrame': 'Baseline (week 0), discharge (week 10) and follow-up (week 14) assessments.', 'description': 'Hand function assessment.'}, {'measure': 'Spinal Cord Independence Measure', 'timeFrame': 'Baseline (week 0), discharge (week 10) and follow-up (week 14) assessments.', 'description': 'Questionnaire about independence on daily tasks.'}], 'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Week 1 to week 14.', 'description': 'Presence of adverse and serious adverse events. These will be recorded during each session. The criterion for success is no study-related serious adverse events and no study-related adverse events that cannot be alleviated by stopping electrical stimulation.'}, {'measure': 'Feasibility - Set-up time', 'timeFrame': 'During experimental sessions from week 1 to week 10.', 'description': 'The study will track independence with the system by assessing set-up time.'}, {'measure': 'Feasibility - Assistance required.', 'timeFrame': 'During experimental sessions from week 1 to week 10.', 'description': 'The study will track independence with the system by assessing the number of times assistance is requested.'}], 'secondaryOutcomes': [{'measure': 'Adherence', 'timeFrame': 'During experimental sessions from week 1 to week 10.', 'description': 'Number of missed sessions.'}, {'measure': 'User feedback', 'timeFrame': 'Discharge assessment at week 10.', 'description': 'Structured and semi-structured interviews.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical spinal cord injury', 'Augmented reality', 'Functional electrical stimulation', 'Neuromodulation'], 'conditions': ['Cervical Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': "Cervical spinal cord injury (cSCI) can result in substantial loss of upper-limb function, with associated socio-economic impact on affected individuals and the healthcare system. Evidence suggests that non-invasive neuromodulation such as functional electrical stimulation (FES) therapy can contribute to regaining upper-limb function, which is a top priority for this population. This pilot study will involve individuals with cSCI using a device that combines augmented reality (AR) and functional electrical stimulation (FES) for 20, one-hour sessions over a 10-week period. The sessions will include upper-limb rehabilitation where individuals will interact with different objects with the aid of the AR +FES system. The primary objective is to assess safety and feasibility, measured by the absence of serious adverse events and participants' ability to independently set up and use the system. Secondary objectives include adherence to the intervention and user feedback through structured interviews. Exploratory outcomes will examine preliminary efficacy using clinical measures such as the Spinal Cord Independence Measure (SCIM) and the Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic cervical SCI\n* Any level or severity of cervical SCI, traumatic or non-traumatic\n* Can carry out object manipulations but with visible impairment (i.e., 5-25 on the GRASSP Prehension Performance sub-score).\n\nExclusion Criteria:\n\n* Any disease or injury other than the SCI that may be affecting grasping performance.\n* Individuals with any self-reported FES contraindications (pacemakers, implantable defibrillator, implanted neurostimulation device, metallic implants in the stimulated areas, cardiac conditions, epilepsy, uncontrolled seizures, wounds or fractures on the target limb)\n* Inability to understand the study procedures\n* Muscles do not respond to FES to produce grasping movements\n* Currently participating in another upper limb rehabilitation intervention study (regular physical and occupational therapy is permitted).'}, 'identificationModule': {'nctId': 'NCT07299734', 'briefTitle': 'Feasibility and Safety of a Combined Augmented Reality and Functional Electrical Stimulation System', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Assessing the Feasibility and Safety of a Combined Closed Loop Functional Electrical Stimulation and Augmented Reality System for Individuals With Cervical Spinal Cord Injury', 'orgStudyIdInfo': {'id': '25-5898'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single group', 'description': 'Participants will go through 1 screening session, 20 experimental sessions (2 sessions per week for 10 weeks), 1 discharge assessment, and 1 follow up assessment (one month after the last experimental session).', 'interventionNames': ['Device: AR + FES']}], 'interventions': [{'name': 'AR + FES', 'type': 'DEVICE', 'description': 'Within each one-hour experimental session, participants will interact with different objects (e.g. block, credit card, marble). They will be wearing an augmented reality (AR) headset and electrodes will be placed over finger flexors, thumb flexors and finger extensors muscles. The AR headset will track hand posture and use the difference between the actual posture and a target posture to regulate functional electrical stimulation (FES) delivered via the electrodes.', 'armGroupLabels': ['Single group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sharmini Atputharaj, MSc', 'role': 'CONTACT', 'email': 'Sharmini.Atputharaj@uhn.ca', 'phone': '416-597-3422', 'phoneExt': '6119'}], 'facility': 'Lyndhurst Centre, Toronto Rehabilitation Institute - University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Sharmini Atputharaj, MSc', 'role': 'CONTACT', 'email': 'Sharmini.Atputharaj@uhn.ca', 'phone': '416-597-3422', 'phoneExt': '6119'}], 'overallOfficials': [{'name': 'José Zariffa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified coded study data may be used or shared with other researchers for future studies. Directly identifying information will be replaced by a number, which will be applied to the study data. The participant key matching the code to the participant will be kept by the UHN study team. This may include storing the coded study data in controlled-access databases or open access, publicly accessible databases.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Training Platform for Trials Leveraging Existing Networks', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}