[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646024":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":25,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":25,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":93,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Implanted Neural and Muscular Interface","EXPERIMENTAL","6 lower limb loss participants who have already been chronically implanted with neural and muscular interfaces to allow for direct stimulation",[13,14],"Device: Chronically Implanted Neural and Muscular Interface","Device: Peripheral Nerve Stimulation (PNS)",{"label":16,"type":10,"description":17,"interventionNames":18},"Peripheral nerve stimulation","30 able body participants and 12 participants with unilateral lower-limb loss with receive peripheral nerve stimulation",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Chronically Implanted Neural and Muscular Interface","The implanted neural and and muscular interface will be used to characterize neurovascular reflex testing (thermal axon reflex \\& pressure-induced vasodilation) and microvascular imaging using Laser Doppler Flowmetry and PAI. Reflex responses will be evaluated under baseline and stimulation conditions (sham, tonic, biomimetic), with direct stimulation performed by the CFINE cohort for modality comparison. Structural-functional relationships will be modeled by integrating metrics from PAI with reflex outcomes.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Peripheral Nerve Stimulation (PNS)","The cutaneous peripheral nerve stimulation interface will be used to characterize neurovascular reflex testing (thermal axon reflex \\& pressure-induced vasodilation) and microvascular imaging using Laser Doppler Flowmetry and PAI. Reflex responses will be evaluated under baseline and stimulation conditions (sham, tonic, biomimetic). Structural-functional relationships will be modeled by integrating metrics from PAI with reflex outcomes.",[9,16],[31],{"name":32,"affiliation":33,"role":34},"Hamid Charkhkar, PhD","Louis Stokes VA Medical Center, Cleveland, OH","PRINCIPAL_INVESTIGATOR",[36,41],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","(216) 791-3800","62924","Hamid.Charkhkar@va.gov",{"name":42,"role":37,"phone":38,"phoneExt":43,"email":44},"Jessica R Jarvela, MS BS","63801","Jessica.Jarvela@va.gov",[46],{"facility":33,"status":25,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Cleveland","Ohio","44106-1702","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-81.69541,41.4995,{"lat":56,"lon":55},[59,60,64],{"name":42,"role":37,"phone":38,"phoneExt":43,"email":44},{"name":61,"role":37,"phone":38,"phoneExt":62,"email":63},"Aarika Sheehan, DPT","65832","Aarika.Sheehan@va.gov",{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":66,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[68],{"name":69,"class":70},"Case Western Reserve University","OTHER","100646024","pns-to-improve-vascular-function-and-limb-health-in-veterans-100646024",false,"NCT07696988","PNS to Improve Vascular Function and Limb Health in Veterans","Peripheral Neural Stimulation to Improve Microvascular Function and Limb Health in Veterans With Diabetic Peripheral Neuropathy","Inclusion Criteria:\n\nInclusion Criteria - All Participants:\n\n* English-speaking\n* Veteran\n\nInclusion Criteria - Diabetic Peripheral Neuropathy (DPN) Participants:\n\n* Confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least 5 years\n* Clinical signs and\u002For symptoms consistent with diabetic peripheral neuropathy Or confirmation of neuropathy via physical exam\n\nInclusion Criteria - Lower Limb Amputees:\n\n* Unilateral transtibial or transfemoral amputation\n* Medically stable for at least 3 months\n* For the designated subset of the limb-loss cohort (n = 6): implanted with C-FINEs on the sciatic and\u002For tibial nerves\n\nExclusion Criteria:\n\nExclusion Criteria - All Participants:\n\n* Severe neurological disorders impairing ambulation\n* Visual or hearing impairments interfering with study participation\n* Cardiovascular or respiratory conditions posing risk during participation\n* Cognitive or psychiatric conditions compromising informed consent\n* Participation in other clinical trials interfering with outcomes\n* Pregnancy\n* History of photosensitivity or known sensitivity to laser light\n\nAdditional Exclusion Criteria - Amputees:\n\n* Active skin breakdown or infection at residual limb\n* Significant phantom or residual limb pain interfering with study procedures\n* Bilateral lower-limb amputation",true,"ALL","18 Years",{"count":82,"type":83},42,"ESTIMATED","INTERVENTIONAL",[86],"NA","Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.",[89,90],"Lower Limb Amputees","Diabetes",[92,90],"lower extremity limb loss","NOT_YET_RECRUITING","2026-08-19",{"date":96,"type":97},"2026-08-21","ACTUAL",{"date":99,"type":83},"2026-11-02",{"date":101,"type":83},"2030-05-30",{"name":5,"class":6},1]