[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"altered-level-of-consciousness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:altered-level-of-consciousness":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100587617","paired-vagus-nerve-stimulation-in-mobilization-of-patients-with-prolonged-disorders-of-consciousness-100587617",false,"NCT06930716","Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness","Use of Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness: A Pilot Feasibility Study","Inclusion Criteria:\n\n* Patients with a diagnosis of pDOC (includes coma, VS\u002FUWS, MCS, MCS +, MCS-) as defined as disorder of consciousness (DOC) greater than 6 weeks post onset\n* Patients deemed medically safe to participate in physical therapy (PT) as evaluated by the study physicians.\n\nExclusion Criteria:\n\n* Patients who have emerged from MCS (CRS-R score 6 on Motor Function scale and\u002For 2 on Communication Scale).\n* Patients medically unsafe for participation in PT as indicated by one of the study physicians (including but not limited to those receiving intravenous sedation, those with integumentary breakdown or known pressure injuries, those with cardiovascular or cerebrovascular conditions precluding initiation of physical therapy \\[ie uncontrolled intracranial pressure, severe symptomatic orthostatic hypotension, etc.).\n* Patients with DOC less than 6 weeks post onset will also be excluded.\n* Patients who do not meet technical requirements of the RTTM device will be excluded\n\n  * weighing greater than 135 kg\n  * length of legs below 75 cm or above 100 cm,\n  * fixed contractures of lower extremity including hip, knee, ankle, or foot).\n* Does not have an identified care partner or legally authorized representative to consent to participation","ALL","22 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"NA","Prolonged disorders of consciousness (pDOC) are defined as DOC lasting \\>1 year post injury for patients with Traumatic Brain Injury (TBI) and \\>3 months post injury for patients with non-TBI and at present there are limited treatments that reliably lead to enhanced prognosis. The rehabilitation process throughout the continuum of care for patients with pDOC necessitates restorative strategies to facilitate arousal and functional recovery and coordinated medical management. Rehabilitation interventions for patients with DOC and pDOC have evolved in the past decade, with an emerging body of evidence highlighting the benefits of rehabilitation intervention even in the acute. While there is data to support the individual utility of these modalities, no work to date has investigated the benefits of pairing transauricular vagus nerve stimulation (taVNS) and robotic tilt table mobilization (RTTM) to maximize functional recovery in patients with pDOC. This study will report on the safety, feasibility, and preliminary short- and long-term outcomes of RTTM with simultaneously paired Transcutaneous auricular vagus nerve stimulation (taVNS) for Severe Acquired Brain Injury (SABI) patients with pDOC . Fifteen (15) participants will be recruited and complete a 12-week rehabilitation protocol using paired taVNS and RTTM. Once participants have been screened and enrolled in the study, they will complete three study phases: T1: a baseline observation of standard of care T2, intervention, and T3 longitudinal follow up.",[26,27,28],"Consciousness Disorders","Brain Injury","Altered Level of Consciousness",[30,31,32],"Therapy","Rehabilitation","Neuromodulation","RECRUITING","2026-06-16",{"date":36,"type":37},"2026-06-18","ACTUAL",{"date":39,"type":37},"2025-08-12",{"date":41,"type":20},"2027-12-30",{"name":43,"class":44},"Icahn School of Medicine at Mount Sinai","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100368678","brain-injured-patients-extubation-readiness-study-100368678","NCT04080440","Brain-injured Patients Extubation Readiness Study","Stepped Wedge Cluster Randomised Controlled Trial to Assess the Readiness of Extubation in Brain-injured Patients Using a Clinical Score","Biper","Inclusion Criteria:\n\n* Acute cerebral lesion with a Glasgow Coma Scale \\\u003C13 needing admission in ICU and mechanical ventilation with tracheal intubation for neurological cause : cerebrovascular stroke either ischemic or hemorrhagic including aneurysmal subarachnoid hemorrhage, traumatic brain injury, anoxo ischemic encephalopathy after cardiac arrest or brain tumour\n* Mechanical ventilation more than 48 hours\n* 18 to 75 years old\n* Neurological stability with no intracranial hypertension with minimal sedation\n* Glasgow Coma Scale motor response \\\u003C 6\n* Spontaneous breathing trial succeeded\n* First extubation attempt\n\nExclusion Criteria:\n\n* Posterior cranial fossa lesion\n* Admission for status epilepticus or central nervous system infection\n* Spinal cord injury (tetraplegia or paraplegia)\n* Uncontrolled status epilepticus or uncontrolled central nervous system infection\n* Care limitation plan\n* Chronic respiratory failure defined as ambulatory oxygen therapy or pressure support ventilation and\u002For proven COPD and\u002For ambulatory non-invasive CPAP therapy for sleep apnoea syndrome\n* More than 3 failed spontaneous breathing trials\n* Significant chest trauma (more than 2 broken ribs \u002F broken sternum \u002F with an indication of open thoracic surgery)\n* Surgery planned within 7 days\n* Tracheotomy or previous extubation outside of the protocol\n* Previous compromised upper airway permeability\n* Pregnant or breastfeeding woman\n* Adult under the protection of the law or without social assurance system\n* Inclusion in another clinical study about mechanical ventilation or weaning","18 Years","75 Years",{"count":57,"type":20},660,[23],"The BIPER study is a stepped wedge cluster randomised clinical trial aiming to decrease extubation failure in critically-ill brain-injured patients with residual impaired consciousness using a simple clinical score.",[61,62,28,63,64],"Mechanical Ventilator Weaning","Acute Brain Injury","Mechanical Ventilation","Airway Control",[66,67,68,69,70,71,72],"Coma","Intensive care units","Critical care","Stroke","Traumatic brain injury","Anoxic ischemic encephalopathy","Glasgow coma scale","2025-09-23",{"date":75,"type":37},"2025-09-24",{"date":77,"type":37},"2020-02-09",{"date":79,"type":20},"2027-10-13",{"name":81,"class":44},"University Hospital, Clermont-Ferrand",21]