[{"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":26,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":26,"enrollmentInfo":42,"targetDuration":26,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":54,"whyStopped":26,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"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",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":43,"type":44},80,"ESTIMATED","INTERVENTIONAL",[47],"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.",[50],"Peripheral Neuropathy",[52,53],"Peripheral neuropathy","Sensory Prosthesis","NOT_YET_RECRUITING","2025-11-22",{"date":57,"type":58},"2025-11-28","ACTUAL",{"date":60,"type":44},"2026-01-01",{"date":62,"type":44},"2028-08-01",{"name":5,"class":6}]