[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560971":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":52,"collaborators":56,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":20,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Ente Ospedaliero Cantonale, Bellinzona","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Muscle electrophysiological signals recording","EXPERIMENTAL","Recording of electrophysiological signals of muscles with a WPM-SEMG prototype",[13],"Device: WPM-SEMG prototype",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","WPM-SEMG prototype","Measurements will be done with the rigid matrix. The flexible electrode matrix will be used only on a lower percentage of volunteers depending on the results obtained with the rigid matrix",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Alain Kaelin, Prof.","CONTACT","+41 (0)91 811 62 57","alain.kaelin@eoc.ch",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Manuela Maffongelli","+41 (0)58 666 65 41","manuela.maffongelli@supsi.ch",[32],{"facility":33,"status":34,"city":35,"state":20,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Neurocentro della Svizzera Italiana","RECRUITING","Lugano","6900","Switzerland","CH",{"type":40,"coordinates":41},"Point",[42,43],8.96004,46.01008,{"lat":43,"lon":42},[46,48],{"name":47,"role":24,"phone":25,"phoneExt":20,"email":26},"Alain Kaelin, Prof",{"name":49,"role":24,"phone":50,"phoneExt":20,"email":51},"Claudio Gobbi, MD","+41 (0)91 811 69 21","claudio.gobbi@eoc.ch",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Alain Kaelin","Prof.",[57,59],{"name":58,"class":6},"University of Applied Sciences and Arts of Southern Switzerland",{"name":60,"class":6},"Clinical Trial Unit Ente Ospedaliero Cantonale","100560971","technical-and-clinical-validation-of-the-wpm-semg-prototype-100560971",false,"NCT06584084","Technical and Clinical Validation of the WPM-SEMG Prototype","Technical and Clinical Validation Study of a New Wireless Portable and Multi-Channel Surface EMG Device to Analyse Motor Unit Action Potentials","Eligibility criteria for healthy volunteers\n\n* Inclusion Criteria\n\n  * Healthy volunteers\n  * Female or male\n  * 18 years or older\n  * Preserved cognitive capacity\n  * Ability to understand the study\n  * Willingness to complete all the study assessments\n  * No chronic or concomitant use of medications or treatment\n  * Written informed consent\n* Exclusion Criteria\n\n  * Skin lesions in the area below the electrode\n  * Allergy to metal alloys\n  * History of skin disease\n  * Pregnancy\n  * Lactation\n  * Known causes of neuromuscular disease\n  * Inability to follow the procedures of the study\n\nEligibility criteria for patients\n\n* Inclusion Criteria\n\n  * Patients of the Neurocentro della Svizzera Italiana with diagnosis of myopathy or neuropathy that requires a needle-EMG electrophysiological testing as standard clinical management of the disease\n  * Female or male\n  * 18 years or older\n  * Preserved cognitive capacity\n  * Ability to understand the study\n  * Willingness to complete all the study assessments\n  * No chronic or concomitant use of medications or treatment that may influence the measure in the opinion of the investigator (muscle relaxant such as baclofen, statin, benzodiazepine).\n  * Written informed consent\n* Exclusion Criteria\n\n  * Skin lesions in the area below the electrode\n  * Allergy to metal alloys\n  * History of skin disease\n  * Cognitive and\u002For psychiatric disorders\n  * Pregnancy\n  * Lactation\n  * Neuromuscular disease other than myopathy and neuropathy\n  * Inability to follow the procedures of the study",true,"ALL","18 Years",{"count":72,"type":73},70,"ESTIMATED","INTERVENTIONAL",[76],"NA","Validation study designed to demonstrate the technical and clinical performance, and the safety of a new medical device in healthy volunteers and patients with myopathy or neuropathy. The medical device is the WPM-SEMG prototype designed for recording electrophysiological signals of muscles.",[79],"Neuron Disease, Motor","2024-09-04",{"date":82,"type":83},"2024-09-19","ACTUAL",{"date":85,"type":83},"2018-01-19",{"date":87,"type":73},"2026-04-30",{"name":54,"class":6},1]