[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507187":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":39,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":18,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Checkpoint Surgical Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Brief Electrical Stimulation Therapy","EXPERIMENTAL","Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.",[13],"Device: Checkpoint BEST System",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","NO_INTERVENTION","Surgical intervention for repair of peripheral nerve injury.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Checkpoint BEST System","Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression\u002Frepair",[9],[26],"Brief Electrical Stimulation (BES) Therapy",[28],{"name":29,"affiliation":30,"role":31},"Amy M Moore, MD","Ohio State University","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Eric Walker, PhD","CONTACT","216-370-9107","101","ewalker@checkpointsurgical.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The Ohio State Univeristy - Department of Plastic and Reconstructive Surgery","RECRUITING","Columbus","Ohio","43212","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-82.99879,39.96118,{"lat":52,"lon":51},[55,59],{"name":56,"role":35,"phone":57,"phoneExt":18,"email":58},"Research Coordinator","614-293-8566","nervenerds@osumc.edu",{"name":29,"role":31,"phone":18,"phoneExt":18,"email":18},{"type":61,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[63],{"name":64,"class":65},"Congressionally Directed Medical Research Programs","FED","100507187","promoting-healing-of-injured-nerves-with-electrical-stimulation-therapy-100507187",false,"NCT05884125","Promoting Healing of Injured Nerves With Electrical Stimulation Therapy","PHINEST","Inclusion Criteria:\n\n* Upper extremity mixed or motor nerve injury from the brachial plexus to the wrist crease.\n* Candidate for surgical intervention.\n* Indicated for surgical repair by nerve transfer, primary repair, or nerve grafting.\n* Are age 18-80 years.\n* Signed and dated informed consent form.\n\nExclusion Criteria:\n\n* Severe comorbid condition, such as arrhythmia or congestive heart failure, preventing surgery.\n* Primary repair requiring graft \\>6cm.\n* Nerve reconstruction occurring \\>12 months post injury.\n* Age less than 18 or greater than 80 years.\n* All contraindications to included\u002Frequired surgical procedure, including but not limited to language barriers, mental status barriers, inability to consent, and pregnancy\u002Flactation.","ALL","18 Years","80 Years",{"count":77,"type":78},60,"ESTIMATED","INTERVENTIONAL",[81],"NA","This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.",[84,85,86,87],"Nerve Injury","Peripheral Nerve Injuries","Peripheral Nerve Injury Upper Limb","Nerve Palsy",[89,90,91,84,92,93],"Therapeutic Electrical Stimulation","Brief Electrical Stimulation","Nerve Regeneration","Nerve Healing","Nerve Repair","2024-08-20",{"date":96,"type":97},"2024-08-21","ACTUAL",{"date":99,"type":97},"2023-06-12",{"date":101,"type":78},"2027-06",{"name":5,"class":6},1]