[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651824":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":69,"collaborators":72,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":20,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":104,"whyStopped":20,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Zhongda Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Epidural Spinal Cord Stimulation","EXPERIMENTAL","Participants will receive epidural spinal cord stimulation in addition to standard neurosurgical, neurocritical care, mechanical ventilation, airway management, and rehabilitation treatment. Respiratory physiological measurements will be obtained before and after stimulation.",[13],"Procedure: Epidural Electrode Implantation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Epidural Electrode Implantation","Participants will undergo surgical implantation of an epidural spinal cord stimulation electrode under anesthesia. The electrode will be positioned at the spinal level specified in the final surgical protocol and connected to a stimulation system.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Fei Peng, PhD. MD.","CONTACT","15950565786","afei0312@163.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Yi Li, PhD.","136 6180 0806","liyi@@ion.ac.cn",[32,49,65],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Chinese PLA General Hospital","Beijing","Beijing Municipality","100000","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46],{"name":47,"role":24,"phone":20,"phoneExt":20,"email":48},"Xiaoyu Xia, Dr. PhD.","jiaxy02@163.com",{"facility":50,"status":20,"city":51,"state":52,"zip":53,"country":37,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Zhongda Hospital, Southeast University","Nanjing","Jiangsu","210009",{"type":40,"coordinates":55},[56,57],118.77778,32.06167,{"lat":57,"lon":56},[60,62],{"name":61,"role":24,"phone":25,"phoneExt":20,"email":26},"Fei Peng, Dr. PhD.",{"name":63,"role":64,"phone":20,"phoneExt":20,"email":20},"Fei Peng, Dr.PhD.","PRINCIPAL_INVESTIGATOR",{"facility":66,"status":20,"city":67,"state":52,"zip":68,"country":37,"countryCode":38,"cosmosGeoPoint":20,"geoPoint":20,"contacts":20},"The 904th Hospital of the Joint Logistic Support Force of the Chinese People's Liberation Army","Suzhu","215000",{"type":64,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Fei Peng","Sub-Investigator",[73,76,78],{"name":74,"class":75},"The 904th Hospital of the People's Liberation Army of China","UNKNOWN",{"name":77,"class":75},"Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences",{"name":33,"class":6},"100651824","epidural-spinal-cord-stimulation-for-respiratory-recovery-in-brain-injury-100651824",false,"NCT07766681","Epidural Spinal Cord Stimulation for Respiratory Recovery in Brain Injury","An Exploratory Clinical Trial of Epidural Spinal Cord Stimulation for Respiratory Recovery in Patients With Brain Injury","BREATH","Inclusion Criteria:\n\n* Age 18 to 74 years. Body mass index less than 30 kg\u002Fm². Imaging-confirmed stroke or traumatic brain injury. Glasgow Coma Scale score of 3 to 8, with relatively stable vital signs. Requirement for invasive mechanical ventilation through an oral or nasal endotracheal tube or tracheostomy for at least 24 hours.\n\nWritten informed consent provided by the participant's legally authorized representative; if the participant regains decision-making capacity, continued participation will be reconfirmed with the participant.\n\nWillingness and ability of the participant or legally authorized representative to comply with the study intervention and follow-up procedures.\n\nExclusion Criteria:\n\n* Suspected or confirmed infection at the planned electrode implantation site, severe uncontrolled systemic infection, known metal allergy relevant to the implanted device, or uncontrolled intracranial hypertension.\n\nRespiratory failure primarily attributable to severe pneumonia, pulmonary contusion, pneumothorax, hemothorax, chronic obstructive pulmonary disease with respiratory failure, severe asthma, or a requirement for home oxygen therapy within the previous 6 months.\n\nNew York Heart Association class III or IV heart failure or presence of an implanted cardiac pacemaker.\n\nSevere hepatic dysfunction, including Child-Pugh class C, severe renal dysfunction with estimated glomerular filtration rate ≤30 mL\u002Fmin\u002F1.73 m², or dialysis dependence.\n\nStatus epilepticus or active convulsions. Cervical spinal cord injury, other spinal cord injury, major chest wall deformity, myasthenia, or respiratory dysfunction primarily caused by brainstem injury.\n\nSevere psychiatric or pre-existing neurological or cognitive disorders that would interfere with study evaluation or completion, including amyotrophic lateral sclerosis, dementia, Parkinson disease, Huntington disease, or another clinically significant central nervous system disorder unrelated to the index brain injury.\n\nExpected survival of 72 hours or less, or a decision to withhold endotracheal intubation, cardiopulmonary resuscitation, or other life-sustaining treatment.\n\nPregnancy or breastfeeding. Any other condition that, in the investigator's judgment, may place the participant at unacceptable risk or interfere with completion of the study.","ALL","18 Years","74 Years",{"count":91,"type":92},10,"ESTIMATED","INTERVENTIONAL",[95],"NA","Patients with severe brain injury may develop impaired respiratory drive, diaphragm dysfunction, prolonged mechanical ventilation, and difficulty recovering spontaneous breathing. Epidural spinal cord stimulation may activate preserved spinal respiratory circuits and improve respiratory muscle activity. This prospective, single-center, non-randomized, single-arm exploratory study will enroll 10 patients with stroke or traumatic brain injury who have impaired consciousness and require invasive mechanical ventilation. Participants will undergo epidural spinal cord stimulation in addition to standard clinical care. Diaphragmatic electrical activity, respiratory function, diaphragm ultrasound findings, diaphragm electromyography, duration of mechanical ventilation, pulmonary infection, length of stay, mortality, safety events, and 6-month neurological outcome will be assessed. The study aims to evaluate the safety and preliminary efficacy of epidural spinal cord stimulation for improving respiratory function after brain injury.",[98,99],"Brain Injuries","Respiratory Failure",[101,102,103],"Epidural spinal cord stimulation","Respiratory failure","Diaphragmatic electrical activity","NOT_YET_RECRUITING","2026-08-09",{"date":107,"type":108},"2026-08-14","ACTUAL",{"date":110,"type":92},"2026-08-05",{"date":112,"type":92},"2028-12-31",{"name":5,"class":6},3]