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Vagus Nerve Stimulation in Patients in Comatose State

RecruitingNAAges 18 Years - anyAllSima Mofakham
NCT07719595 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Coma, vegetative state/unresponsive wakefulness syndrome (VS/UWS), 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 Exclusion Criteria: * Implanted cardiac pacemaker, vagus nerve stimulator, or other active implanted device * Known cardiac arrhythmia (e.g., 2nd-/3rd-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
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What it tests

  • Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS)
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Where

1 site
Stony Brook University Hospital
Stony Brook, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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