Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT05980767
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2023-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009443', 'term': 'Neuritis'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Electromyography (EMG) Denervation Absence/Presence', 'timeFrame': '1.5 years', 'description': 'Measurement of electrical activity of a muscle'}, {'measure': 'Nerve Conduction Study (NCS)', 'timeFrame': '1.5 years', 'description': 'Measurement of speed of electrical impulse through a nerve'}, {'measure': 'Semmes-Weinstein Monofilament Test', 'timeFrame': '1.5 years', 'description': 'Evaluation of sensory recovery through the measurement of a pressure detection threshold'}, {'measure': 'Static Two-Point Discrimination', 'timeFrame': '1.5 years', 'description': 'Evaluation of sensory recovery through the measurement of the threshold of discrimination'}, {'measure': 'Grip strength', 'timeFrame': '1.5 years', 'description': 'Evaluation of functional recovery through the measurement of maximum grip strength'}, {'measure': 'Pinch strength', 'timeFrame': '1.5 years', 'description': 'Evaluation of functional recovery through the measurement of pinch strength'}, {'measure': 'Patient Rated Ulnar Nerve Evaluation (PRUNE)', 'timeFrame': '1.5 years', 'description': 'Evaluation of pain and quality of life through patient-reported questionnaire where lower scores indicate lower pain and better quality of life related to the injury'}], 'primaryOutcomes': [{'measure': 'Eligibility Rate', 'timeFrame': '1.5 years', 'description': 'Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria'}, {'measure': 'Recruitment Rate', 'timeFrame': '1.5 years', 'description': 'Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm'}, {'measure': 'Retention Rate', 'timeFrame': '1.5 years', 'description': 'Evaluation of study feasibility through the number of participants who complete all study activities'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuropathy;Peripheral']}, 'descriptionModule': {'briefSummary': 'A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ulnar neuropathy at the elbow\n\nExclusion Criteria:\n\n* Peripheral neuropathy outside of nerve of interest\n* Patients with any active implanted device'}, 'identificationModule': {'nctId': 'NCT05980767', 'acronym': 'SELECT', 'briefTitle': 'Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epineuron Technologies Inc.'}, 'officialTitle': 'Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial', 'orgStudyIdInfo': {'id': 'EPNR-CIP-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental Intervention', 'description': 'Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.', 'interventionNames': ['Device: Temporary Peripheral Nerve Stimulation System']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care only.'}], 'interventions': [{'name': 'Temporary Peripheral Nerve Stimulation System', 'type': 'DEVICE', 'description': 'Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.', 'armGroupLabels': ['Experimental Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dr. James Bain, MD, MSc, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr. Hyosuk (Brian) Chin, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dr. Genevieve Dostaler, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dr. Adrian Opala, MD, FRCPC, CSCN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'McMaster University Medical Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Katelyn So, MHSc', 'role': 'CONTACT', 'email': 'clinops@epineurontech.com', 'phone': '905-206-0466'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epineuron Technologies Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Federal Economic Development Agency for Southern Ontario (FedDev Ontario)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}