[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100447796":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Ecole Polytechnique Fédérale de Lausanne","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"all participants","EXPERIMENTAL","All participants will be provided with the ARC-IM Investigational System (implantable and non-implantable parts)",[13],"Device: ARC-IM Investigational System implantation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","ARC-IM Investigational System implantation","Implantation of a stimulation lead on the low thoracic level of the spinal cord and implantation of a neurostimulator in the abdominal region.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Jocelyne Bloch, MD","CHUV","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Gregoire Courtine, Prof","CONTACT","+41 21 69 30762","gregoire.courtine@epfl.ch",[33],{"facility":24,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":41,"coordinates":42},"Point",[43,44],6.63282,46.516,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":20,"phoneExt":20,"email":20},"Jocelyne Dr Bloch, Prof. Dr.",{"type":25,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":52,"oldNameTitle":20,"oldOrganization":20},"Jocelyne Bloch","Prof.","Centre Hospitalier Universitaire Vaudois","100447796","epidural-electrical-stimulation-to-restore-hemodynamic-stability-and-trunk-control-in-people-with-spinal-cord-injury-100447796",false,"NCT05111093","Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury","HemON","Inclusion Criteria:\n\n* 18 years of age or older\n* Must provide and sign the Informed Consent prior to any study related procedures\n* Spinal cord injury lesion level between C3 and T6 (inclusive)\n* SCI ≥ 1month\n* Confirmed orthostatic hypotension\n* Stable medical, physical and psychological condition as considered by the investigators\n* Able to understand and interact with the study team in French or English\n* Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments\n\nExclusion Criteria:\n\n* SCI related to a neurodegenerative disease\n* Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery\n* The inability to withhold antiplatelet\u002Fanticoagulation agents perioperatively\n* History of myocardial infarction or cerebrovascular event within the past 6 months\n* Other conditions that would make the subject unable to participate in testing in the judgement of the investigators\n* Clinically significant mental illness in the judgement of the investigators\n* Botulinum toxin vesical and non-vesical injections in the previous 3 months before the enrolment\n* Presence of significant pressure ulcers\n* Recurrent urinary tract infection refractory to antibiotics\n* Presence of indwelling baclofen or insulin pump\n* Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding,\n* Lack of safe contraception for women of childbearing capacity,\n* Intention to become pregnant during the course of the study,\n* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant,\n* Participation in another study with investigational drug within the 30 days preceding and during the present study,\n* Enrolment of the investigator, his\u002Fher family members, employees, and other dependent persons.","ALL","18 Years",{"count":63,"type":64},20,"ESTIMATED","INTERVENTIONAL",[67],"NA","The HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to improve hemodynamic management and trunk control in people with sub-acute or chronic spinal cord injury (\\>= 1 month post injury) between C3 and T6 inclusive, who suffer from orthostatic hypotension.",[70],"Spinal Cord Injuries",[72],"Spinal Cord Injury","2025-05-26",{"date":75,"type":76},"2025-05-30","ACTUAL",{"date":78,"type":76},"2021-11-29",{"date":80,"type":64},"2030-12-31",{"name":5,"class":6},1]