[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100447796":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":33,"interventions":40,"overallOfficials":46,"centralContacts":51,"locations":57,"responsibleParty":74,"collaborators":26,"id":78,"slug":26,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":26,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":59,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Ecole Polytechnique Fédérale de Lausanne","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Investigational System","Evaluate the safety of ARC-IM Therapy at supporting management of hemodynamic instability in participants with sub-acute or chronic spinal cord injury suffering from orthostatic hypotension","Throughout study, an average of 26 months",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Orthostatic head-up tilt test (hemodynamic stability assessment)","Participant begin by resting in the supine position during which baseline measures are performed. Thereafter, participant is passively moved to upright position using a tilt-table and kept in this position for a maximum of 10 minutes. This test will be performed with and without ARC-IM Therapy. Beat by beat blood pressure is monitored and catecholamine concentrations in the plasma are measured during the tilt-test.","Baseline ; at 1 - 6.5 - 13 - 26 months after the implantation",{"measure":19,"description":20,"timeFrame":21},"Modified Ashworth Scale (MAS) (spasticity assessment)","Participants' upper and lower limb spasticity levels (6 points nominal scale) are assessed by rating the resistance of a muscle to a passive range of motion about a single joint. This test will be performed with and without ARC-IM Therapy.\n\nScores range from 0 to 5 (0, 1, 1+, 2, 3, 4, 5) with higher scores indicating higher spasticity.","Baseline ; at 1 - 13 months after the implantation",{"measure":23,"description":24,"timeFrame":25},"SCIM III (daily life performance assessment)","The Spinal Cord Independence Measure (SCIM) is a disability score to assess functional activity in participants. Function is assessed in 3 areas of function: self-care (0-20), respiration and sphincter management (0-40) and mobility (0-40). Total score ranges between 0-100, with higher scores reflecting greater functional ability","Baseline ; at 1 - 6.5 - 13 months after the implantation",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"all participants","EXPERIMENTAL","All participants will be provided with the ARC-IM Investigational System (implantable and non-implantable parts)",[39],"Device: ARC-IM Investigational System implantation",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":26},"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.",[35],[47],{"name":48,"affiliation":49,"role":50},"Jocelyne Bloch, MD","CHUV","PRINCIPAL_INVESTIGATOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":26,"email":56},"Gregoire Courtine, Prof","CONTACT","+41 21 69 30762","gregoire.courtine@epfl.ch",[58],{"facility":49,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":66,"coordinates":67},"Point",[68,69],6.63282,46.516,{"lat":69,"lon":68},[72],{"name":73,"role":54,"phone":26,"phoneExt":26,"email":26},"Jocelyne Dr Bloch, Prof. Dr.",{"type":50,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":77,"oldNameTitle":26,"oldOrganization":26},"Jocelyne Bloch","Prof.","Centre Hospitalier Universitaire Vaudois","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":87,"type":88},20,"ESTIMATED","INTERVENTIONAL",[28],"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.",[93],"Spinal Cord Injuries",[95],"Spinal Cord Injury","2025-05-26",{"date":98,"type":99},"2025-05-30","ACTUAL",{"date":101,"type":99},"2021-11-29",{"date":103,"type":88},"2030-12-31",{"name":5,"class":6},1]