[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07719595":3,"trial-entities:NCT07719595":98,"trial-summary:NCT07719595":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":44,"secondary_outcomes":52,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":74,"locations":77,"central_contacts":93,"overall_officials":95,"references":96,"see_also_links":97},"NCT07719595","IRB2019-00199 MOD061","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","RECRUITING","2029-12","2026-06","2026-07-22","2026-06-26","Sima Mofakham","OTHER",false,"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.","This prospective, single-center, open-label, single-arm pilot study enrolls a subcohort of comatose TBI patients from the parent SeeMe study (NCT07560631) whose legally authorized representative consents to a stimulation addendum. Dual-site transcutaneous auricular nerve stimulation is delivered to the left ear: the vagal site (cymba conchae) targets the auricular branch of the vagus nerve, and the trigeminal site (outer ear) targets the auriculotemporal branch - each with distinct, optimized parameters. Mechanistically, vagal afferents project to the nucleus tractus solitarius and the ascending reticular activating system to promote arousal, while trigeminal afferents project via the spinal trigeminal nucleus to thalamus and cortex to enhance thalamocortical connectivity; the dual-site paradigm aims to drive the cortico-striatal-thalamic-cortical loop from two convergent directions. Baseline assessment captures CRS-R, GCS, vital signs, NCS-R, heart-rate variability, and EEG. Daily one-hour sessions include pre\u002Fpost vitals, NCS-R-guided titration, continuous telemetry, ear-site inspection, and daily CRS-R. In parallel, the SeeMe computer-vision platform quantifies stimulus-evoked facial and hand movements. The course runs 7 consecutive days, extendable to 28 days. Findings will inform a future sham-controlled randomized trial and closed-loop integration with SeeMe.",[19,20,21,22],"Traumatic Brain Injury","Severe Traumatic Brain Injury","Disorders of Consciousness Due to Severe Brain Injury","Coma, Traumatic",[24,25,26,27,28,29],"taVNS","taTNS","transcutaneous auricular vagus nerve stimulation","trigeminal nerve stimulation","dual-site neuromodulation","coma","INTERVENTIONAL","TREATMENT",[33],"NA",{"count":35,"type":36},10,"ESTIMATED",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42},"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.",[43],"Dual-site auricular stimulation (taVNS + taTNS)",[45,49],{"measure":46,"description":47,"timeFrame":48},"Change in Coma Recovery Scale-Revised (CRS-R) Total Score","Change in level of consciousness will be assessed using the Coma Recovery Scale-Revised total score. The outcome will be reported as the within-participant change in total score from baseline to the end of treatment, as scored by a trained assessor. Scores range from 0 to 23, with higher scores indicating better neurobehavioral function and greater recovery of consciousness.","Baseline to Day 7, or baseline to Day 28 for participants with extended treatment",{"measure":50,"description":51,"timeFrame":48},"Change in SeeMe-Detected Stimulus-Evoked Voluntary Motor Responses","Change in command-evoked voluntary motor responses will be assessed using the SeeMe automated camera-based detection system. The outcome will be reported as the within-participant change in the percentage of command trials with SeeMe-positive responses from baseline to the end of treatment. Scores range from 0% to 100%, with higher percentages indicating more frequent command-evoked voluntary motor responses. A SeeMe-positive response is defined as a Kolmogorov-Smirnov statistic greater than 0.1 and pixel displacement greater than 400, detected reliably in at least 3 of 10 command trials. SeeMe scoring will be automated and performed blinded to stimulation timing.",[53],{"measure":54,"description":55,"timeFrame":48},"Number of Participants With Device- or Stimulation-Related Adverse Events","Adverse events attributed to auricular stimulation will be recorded and graded using CTCAE v5.0, including ear-site skin reactions, bradycardia or other arrhythmia, oxygen desaturation, and hemodynamic instability. Events requiring NCS-R-guided dose reduction or meeting prespecified stopping criteria will be reported.","ALL","18 Years",null,{"inclusion":60,"exclusion":66,"raw_text":73},[61,62,63,64,65],"Age ≥ 18 years","Coma, vegetative state\u002Funresponsive wakefulness syndrome (VS\u002FUWS), or minimally conscious state (MCS) as determined by baseline CRS-R","Acute traumatic brain injury with documented intracranial pathology on neuroimaging","Admission to the Neurology or Neurosurgical ICU","Legally authorized representative (LAR) available and willing to consent, including the Stimulation Addendum Consent Form",[67,68,69,70,71,72],"Implanted cardiac pacemaker, vagus nerve stimulator, or other active implanted device","Known cardiac arrhythmia (e.g., 2nd-\u002F3rd-degree AV block, atrial fibrillation with uncontrolled rate)","Active seizures not controlled by current antiepileptic regimen","Skin breakdown, infection, or anatomical abnormality of the left ear precluding electrode placement","Pregnancy","Hemodynamic instability requiring vasopressor escalation at the time of enrollment","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",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":90},"Stony Brook University Hospital","Stony Brook","New York","11794","United States",[85],{"name":86,"role":87,"phone":88,"email":89},"Sima Mofakham, PhD","CONTACT","631-444-1278","sima.mofakham@stonybrookmedicine.edu",{"lat":91,"lon":92},40.92565,-73.14094,[94],{"name":86,"role":87,"phone":88,"email":89},[],[],[],{"nct_id":4,"conditions":99,"biomarkers":105},[100,101,102,103,104],"Coma","Minimally conscious state","Traumatic Encephalopathy","Unresponsive Wakefulness Syndrome","Vegetative State",[],{"nct_id":4,"found":107,"summary":108,"prompt_version":118},true,{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is a small, single-center pilot study involving 10 participants. All participants will receive the Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS) intervention.","completed","Vagus Nerve Stimulation for Comatose Patients with Traumatic Brain Injury","This study is exploring a gentle, non-invasive treatment for patients in a coma or with other disorders of consciousness due to severe traumatic brain injury. The treatment, called Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS), uses ear-clip electrodes on the left ear to stimulate two nerves at once: the vagus nerve and the trigeminal nerve. Researchers believe stimulating these nerves may help promote arousal and improve brain connections. All 10 enrolled patients will receive this stimulation for one hour a day. The study will measure changes in their Coma Recovery Scale-Revised (CRS-R) scores and voluntary movements to see if the treatment helps them recover. This study is currently recruiting patients.","Participants will be assessed at baseline to Day 7, or baseline to Day 28 for those with extended treatment.",111,"Participants will receive daily one-hour stimulation sessions. They will have continuous heart and oxygen monitoring, and their ear site will be inspected daily.","Not stated in the trial record.",[40],"v2"]