[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648390":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Stony Brook University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dual-site auricular stimulation (taVNS + taTNS)","EXPERIMENTAL","Experimental: Dual-site auricular stimulation (taVNS + taTNS). All enrolled participants receive active vagal and trigeminal auricular stimulation.",[13],"Device: Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS)","DEVICE: Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS). Delivered via ear-clip electrodes on the LEFT ear using the Sparrow Ascent \u002F Sparrow Link tAN System (Spark Biomedical; FDA-cleared K230796), operated as an NSR investigational device. Vagal site (inner ear \u002F cymba conchae): 15 Hz, 250 µs pulse width, 3 mA fixed, duty cycle 5 min on \u002F 10 s off. Trigeminal site (outer ear): 100 Hz, 250 µs pulse width, 3 mA fixed, duty cycle 5 min on \u002F 10 s off. Session: 1 hour\u002Fday. Course: 7 consecutive days, extendable to 28 days. Intensity titrated with the Nociception Coma Scale-Revised (NCS-R): step down 0.5 mA if NCS-R \\> 4\u002F9, SpO2 ≤ 95%, or HR rises ≥ 20 bpm; continuous cardiac\u002Fhemodynamic monitoring with prespecified stopping rules.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Sima Mofakham, PhD","CONTACT","631-444-1278","sima.mofakham@stonybrookmedicine.edu",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Stony Brook University Hospital","RECRUITING","Stony Brook","New York","11794","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-73.14094,40.92565,{"lat":40,"lon":39},[43],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Sima Mofakham","Associate Professor of Neurosurgery",[49],{"name":50,"class":51},"National Institute of Mental Health (NIMH)","NIH","100648390","vagus-nerve-stimulation-in-patients-in-comatose-state-100648390",false,"NCT07719595","Vagus Nerve Stimulation in Patients in Comatose State","Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS) for Disorders of Consciousness After Traumatic Brain Injury: A Pilot Efficacy Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Coma, vegetative state\u002Funresponsive wakefulness syndrome (VS\u002FUWS), or minimally conscious state (MCS) as determined by baseline CRS-R\n* Acute traumatic brain injury with documented intracranial pathology on neuroimaging\n* Admission to the Neurology or Neurosurgical ICU\n* Legally authorized representative (LAR) available and willing to consent, including the Stimulation Addendum Consent Form\n\nExclusion Criteria:\n\n* Implanted cardiac pacemaker, vagus nerve stimulator, or other active implanted device\n* Known cardiac arrhythmia (e.g., 2nd-\u002F3rd-degree AV block, atrial fibrillation with uncontrolled rate)\n* Active seizures not controlled by current antiepileptic regimen\n* Skin breakdown, infection, or anatomical abnormality of the left ear precluding electrode placement\n* Pregnancy\n* Hemodynamic instability requiring vasopressor escalation at the time of enrollment","ALL","18 Years",{"count":62,"type":63},10,"ESTIMATED","INTERVENTIONAL",[66],"NA","Some patients with severe traumatic brain injury cannot respond at the bedside, yet about 1 in 4 may be aware but unable to show it - a hidden state called cognitive motor dissociation. This study tests a gentle, non-invasive treatment delivered through clips on the left ear that stimulates two nerves at once: the vagus nerve at the inner ear (taVNS) and the trigeminal nerve at the outer ear (taTNS). Each nerve has separately been shown to help people with disorders of consciousness recover, but they have not been combined before. All enrolled patients receive the stimulation for one hour a day, with continuous heart and oxygen monitoring and a pain-protection check used to keep the dose safe. The study measures recovery two ways: the Coma Recovery Scale-Revised (CRS-R), scored by clinicians, and SeeMe, an automated camera system that detects tiny command-driven movements the eye cannot see.",[69,70,71,72],"Traumatic Brain Injury","Severe Traumatic Brain Injury","Disorders of Consciousness Due to Severe Brain Injury","Coma, Traumatic",[74,75,76,77,78,79],"taVNS","taTNS","transcutaneous auricular vagus nerve stimulation","trigeminal nerve stimulation","dual-site neuromodulation","coma","2026-07-17",{"date":82,"type":83},"2026-07-22","ACTUAL",{"date":85,"type":83},"2026-06-26",{"date":87,"type":63},"2029-12",{"name":46,"class":6},1]