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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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

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

Sponsor: Sima Mofakham · Participants: 10 · Started: Jun 26, 2026

Contact the study team

• Sima Mofakham, PhD · Phone: 631-444-1278

Official record on ClinicalTrials.gov — NCT07719595

Locations in the U.S.

Conditions

• Traumatic Brain Injury
• Coma

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.