Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT04662320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-05
First Post:
2020-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Healing of Nerves Through Electrical Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020430', 'term': 'Cubital Tunnel Syndrome'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D020424', 'term': 'Ulnar Neuropathies'}], 'ancestors': [{'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017769', 'term': 'Ulnar Nerve Compression Syndromes'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Grip Strength at 1 year.', 'timeFrame': '1 year', 'description': 'Change in grip strength at 1 year from baseline (pre-operative) assessment.'}], 'secondaryOutcomes': [{'measure': 'Grip Strength', 'timeFrame': 'Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year', 'description': 'Maximum grip strength'}, {'measure': 'Lateral Pinch Strength', 'timeFrame': 'Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year', 'description': 'Maximum lateral pinch strength'}, {'measure': '2-point discrimination', 'timeFrame': 'Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year', 'description': 'Evaluation of sensory function, measuring tactile discrimination.'}, {'measure': 'Semmes-Weinstein Monofilament Testing', 'timeFrame': 'Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year', 'description': 'Evaluation of sensory function, measuring pressure detection threshold.'}, {'measure': 'Medical Research Council (MRC) motor grading.', 'timeFrame': 'Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year', 'description': 'Grading of muscle strength on 0 to 5 scale, with higher score representing greater function.'}, {'measure': 'Maximal finger spread measurement.', 'timeFrame': 'Pre-surgery, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year', 'description': 'Measurement of maximal finger spread.'}, {'measure': 'Patient Reported Outcome Measurement System (PROMIS) Upper Extremity Function', 'timeFrame': 'Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year', 'description': 'Questionnaire providing patient reported estimate of upper extremity function on a 0-100 scale with \\>50 representing greater normal function.'}, {'measure': 'Patient Reported Outcome Measurement System (PROMIS) Pain Interference', 'timeFrame': 'Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year', 'description': 'Questionnaire providing patient reported estimate of interference of pain on daily activities on a 0-100 scale with \\>50 representing greater than normal pain interference on daily activities.'}, {'measure': 'Michigan Hand Questionnaire (MHQ)', 'timeFrame': 'Pre-surgery, 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year', 'description': 'MHQ is a patient reported estimate of hand function on a 0-100 scale with a higher number indication greater hand function.'}, {'measure': 'Nerve Conduction Velocity (NCV)', 'timeFrame': 'Pre-surgery, 3 months, and 7 months', 'description': 'Measurement of how quickly an electrical impulse moves along the nerve.'}, {'measure': 'Electromyography (EMG)', 'timeFrame': 'Pre-surgery, 3 months, and 7 months', 'description': 'Measurement of the electrical activity in a muscle.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Therapeutic Electrical Stimulation', 'Nerve Regeneration', 'Nerve Healing', 'Nerve Injury', 'Cubital Tunnel', 'Ulnar Nerve'], 'conditions': ['Cubital Tunnel Syndrome', 'Nerve Compression', 'Nerve Injury', 'Ulnar Neuropathies']}, 'referencesModule': {'references': [{'pmid': '38600968', 'type': 'BACKGROUND', 'citation': 'Saffari TM, Walker ER, Pet MA, Moore AM. Brief Intraoperative Electrical Stimulation to Enhance Nerve Regeneration. Plast Reconstr Surg Glob Open. 2024 Apr 10;12(4):e5730. doi: 10.1097/GOX.0000000000005730. eCollection 2024 Apr. No abstract available.'}, {'pmid': '31432080', 'type': 'BACKGROUND', 'citation': 'Power HA, Morhart MJ, Olson JL, Chan KM. Postsurgical Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial. Neurosurgery. 2020 Jun 1;86(6):769-777. doi: 10.1093/neuros/nyz322.'}, {'pmid': '19800329', 'type': 'BACKGROUND', 'citation': 'Gordon T, Amirjani N, Edwards DC, Chan KM. Brief post-surgical electrical stimulation accelerates axon regeneration and muscle reinnervation without affecting the functional measures in carpal tunnel syndrome patients. Exp Neurol. 2010 May;223(1):192-202. doi: 10.1016/j.expneurol.2009.09.020. Epub 2009 Oct 1.'}, {'pmid': '31397919', 'type': 'BACKGROUND', 'citation': 'Jo S, Pan D, Halevi AE, Roh J, Schellhardt L, Hunter Ra DA, Snyder-Warwick AK, Moore AM, Mackinnon SE, Wood MD. Comparing electrical stimulation and tacrolimus (FK506) to enhance treating nerve injuries. Muscle Nerve. 2019 Nov;60(5):629-636. doi: 10.1002/mus.26659. Epub 2019 Aug 21.'}, {'pmid': '33794683', 'type': 'BACKGROUND', 'citation': 'Evans A, Padovano WM, Patterson JMM, Wood MD, Fongsri W, Kennedy CR, Mackinnon SE. Beyond the Cubital Tunnel: Use of Adjunctive Procedures in the Management of Cubital Tunnel Syndrome. Hand (N Y). 2023 Mar;18(2):203-213. doi: 10.1177/1558944721998022. Epub 2021 Apr 2.'}, {'pmid': '34668879', 'type': 'BACKGROUND', 'citation': 'Sayanagi J, Acevedo-Cintron JA, Pan D, Schellhardt L, Hunter DA, Snyder-Warwick AK, Mackinnon SE, Wood MD. Brief Electrical Stimulation Accelerates Axon Regeneration and Promotes Recovery Following Nerve Transection and Repair in Mice. J Bone Joint Surg Am. 2021 Oct 20;103(20):e80. doi: 10.2106/JBJS.20.01965.'}, {'pmid': '35139047', 'type': 'BACKGROUND', 'citation': 'Roh J, Schellhardt L, Keane GC, Hunter DA, Moore AM, Snyder-Warwick AK, Mackinnon SE, Wood MD. Short-Duration, Pulsatile, Electrical Stimulation Therapy Accelerates Axon Regeneration and Recovery following Tibial Nerve Injury and Repair in Rats. Plast Reconstr Surg. 2022 Apr 1;149(4):681e-690e. doi: 10.1097/PRS.0000000000008924.'}]}, 'descriptionModule': {'briefSummary': 'This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for nerve compression. A single dose of the therapeutic stimulation is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow.', 'detailedDescription': 'Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. This study is investigating the use of a single dose of therapeutic electrical stimulation to promote nerve healing. The therapy is delivered as part of the surgical intervention to address compression of the ulnar nerve at the elbow, commonly referred to as Cubital Tunnel Syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Electrodiagnostic evidence of ulnar neuropathy at the elbow.\n* Are candidates for surgical intervention.\n* Evidence of motor involvement such as intrinsic muscle atrophy or weakness.\n* Are age 18-80 years.\n* Signed and dated informed consent form.\n\nExclusion Criteria:\n\n* Severe comorbid condition, such as arrythmia or congestive heart failure, preventing surgery\n* Previous history or current transection of ulnar nerve, or concomitant upper extremity nerve injury\n* Global peripheral neuropathy affecting the hands\n* Age less than 18 or greater than 80 years\n* Un-affected hand maximum grip strength \\<12kg'}, 'identificationModule': {'nctId': 'NCT04662320', 'acronym': 'PHONES', 'briefTitle': 'Promoting Healing of Nerves Through Electrical Stimulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Checkpoint Surgical Inc.'}, 'officialTitle': 'Promoting Healing of Nerves Through Electrical Stimulation', 'orgStudyIdInfo': {'id': '0153-CSP-001'}, 'secondaryIdInfos': [{'id': 'W81XWH1920065', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense USAMRAA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief Electrical Stimulation', 'description': 'Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.', 'interventionNames': ['Device: Checkpoint BEST System']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Surgical intervention for cubital tunnel decompression.'}], 'interventions': [{'name': 'Checkpoint BEST System', 'type': 'DEVICE', 'otherNames': ['Brief Electrical Stimulation (BES) Therapy'], 'description': 'Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair.\n\nOther Name: Checkpoint BEST System', 'armGroupLabels': ['Brief Electrical Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Feinberg School of Medicine - Department of Orthopaedic Surgery', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin - Hand Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Amy M Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ohio State Univeristy Department of Plastic and Reconstructive Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Checkpoint Surgical Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Congressionally Directed Medical Research Programs', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}