[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510562":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":56,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":24,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":24,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ARDS cohort","EXPERIMENTAL","Patient diagnosed with ARDS. Treated daily for 60 minutes with transcutaneous cervical and\u002For thoracic spinal stimulation",[13],"Device: Transcutaneous Biopac Electrical Stimulator",{"label":15,"type":10,"description":16,"interventionNames":17},"Surgery Cohort (Active)","Patient undergoing inpatient non-cardiac surgery admitted to the intensive care unit (ICU) after surgery. Treated daily for 60 minutes with transcutaneous cervical and\u002For thoracic spinal stimulation",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Transcutaneous Biopac Electrical Stimulator","A transcutaneous electrical stimulator sends low levels of electrical current through surface hydrogel electrodes directly to the spinal cord to improve function.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Daniel Lu, MD, PhD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":24,"email":33},"CONTACT","310-825-4321","dclu@mednet.ucla.edu",{"name":35,"role":31,"phone":36,"phoneExt":24,"email":37},"James C Leiter, MD","603-650-6130","jleiter@mednet.ucla.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Los Angeles","California","90095","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-118.24368,34.05223,{"lat":50,"lon":49},[53],{"name":54,"role":31,"phone":55,"phoneExt":24,"email":33},"Daniel C Lu, MD, PhD","310-267-2975",{"type":28,"investigatorFullName":27,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Professor, Neurosurgery","100510562","spinal-cord-stimulation-to-shorten-ventilator-dependence-in-ards-patients-100510562",false,"NCT05928052","Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients","Transcutaneous Spinal Cord Stimulation to Improve Respiratory Function and Shorten Ventilator Dependence in Patients with ARDS","Inclusion Criteria:\n\n1. Male or female 18-85 years;\n2. Intubated with confirmed diagnosis of ARDS (by Berlin Criteria: acute onset within one week of known insult, bilateral airspace opacities not fully explained by pleural effusions, atelectasis, and\u002For nodules, respiratory failure not explained by heart failure or fluid overload, PaO2\u002FFiO2 ratio \\\u003C 300); or identified as a patient admitted to the intensive care unit (ICU) after non-cardiac surgery;\n3. Able to provide informed consent or available next of kin able to provide informed consent;\n4. Have intact chest\u002Flung, upper and lower extremity anatomy;\n5. The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact;\n6. Enrollment of subject within 48 hours of intubation;\n7. Able to induce evoked response of diaphragm muscle by spinal cord TES.\n\nExclusion Criteria:\n\n1. Phrenic nerve or diaphragm pacer;\n2. History of seizure disorder or on anti-epileptic medication for the treatment of seizures;\n3. Compromised skin in back (neck, upper and lower back);\n4. Pregnancy;\n5. Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers;\n6. BMI greater than or equal to 35;\n7. Pharmacological paralysis\u002Fneuromuscular blockade\\*.","ALL","18 Years",{"count":68,"type":69},20,"ESTIMATED","INTERVENTIONAL",[72],"NA","This is an early phase, proof-of-concept clinical trial assessing the safety and feasibility of non-invasive spinal cord stimulation to prevent respiratory muscle atrophy in mechanically ventilated ARDS patients. The investigators will recruit 10 elective surgery patients (surgery cohort) and 10 ARDS patients (ARDS cohort) for this study. A non-invasive, alpha-prototype Restore Technology stimulator using hydrogel surface electrodes will be used to stimulate the spinal cord at the cervical or thoracic level.",[75],"Respiratory Distress Syndrome",[75],"2025-03-07",{"date":79,"type":80},"2025-03-10","ACTUAL",{"date":82,"type":80},"2023-04-18",{"date":84,"type":69},"2029-01-06",{"name":5,"class":6},1]