[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611125":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":35,"sex":41,"minAge":42,"maxAge":26,"enrollmentInfo":43,"targetDuration":26,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":55,"whyStopped":26,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":26},{"fullName":5,"class":6},"MYNERVA AG","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Device","EXPERIMENTAL","Participants use the active wearable device during the study period.",[13],"Device: Active wearable device",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Device","SHAM_COMPARATOR","Participants use a sham version of the wearable device without active functionality.",[19],"Device: Sham wearable device",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active wearable device","A non-invasive wearable device used to assess balance, gait, and usability in individuals with peripheral neuropathy.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham wearable device","A sham version of the wearable device without active functionality.",[15],{"type":32,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100611125","randomized-sham-controlled-investigation-of-the-leia-sensory-prosthesis-in-individuals-with-peripheral-neuropathy-100611125",false,"NCT07236515","Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy","Randomized, Sham-Controlled, Multicenter Investigation of the Leia Sensory Prosthesis on Gait and Balance in Peripheral Neuropathy.","MYN-L001-001","Inclusion Criteria:\n\n* Signed informed consent prior to any study procedure.\n\n  * Adults ≥18 years.\n  * Clinical diagnosis of peripheral neuropathy.\n  * Willingness and ability to attend weekly sessions, perform home use, and return for follow-up.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years at the time of consent.\n* Active foot ulcer, infection, or severe dermatological condition at electrode contact sites.\n* Cognitive impairment that precludes informed consent or device use.\n* Implanted electrical devices or pacemakers.\n* Pregnancy\n* Usage of other medical devices for the relief of neuropathic symptoms during the trials.","ALL","18 Years",{"count":44,"type":45},80,"ESTIMATED","INTERVENTIONAL",[48],"NA","This study will evaluate a wearable device intended to support balance and gait in adults with peripheral neuropathy. Participants will use the device for a defined period, and outcomes related to safety, usability, and functional performance will be assessed.",[51],"Peripheral Neuropathy",[53,54],"Peripheral neuropathy","Sensory Prosthesis","NOT_YET_RECRUITING","2025-11-22",{"date":58,"type":59},"2025-11-28","ACTUAL",{"date":61,"type":45},"2026-01-01",{"date":63,"type":45},"2028-08-01",{"name":5,"class":6}]