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.
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
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
Sima Mofakham
Lead sponsor
Stony Brook University
Sponsor institution
National Institute of Mental Health (NIMH)
Collaborator