Dual-Site Ear Nerve Stimulation for Severe Brain Injury-Related Coma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, open-label pilot study enrolling comatose TBI patients whose consent is provided by a legally authorized representative. The intervention combines two non-invasive ear stimulations (taVNS and taTNS) delivered for one hour daily over 7 days, with potential extension up to 28 days, and continuous safety monitoring. Outcomes are assessed with the Coma Recovery Scale-Revised (CRS-R) and SeeMe, an automated camera system that detects subtle, stimulus-driven movements. The study aims to determine if dual-site stimulation can enhance arousal and thalamocortical connectivity, informing a future sham-controlled trial and integration with SeeMe. Baseline and daily assessments include vital signs, EEG, heart-rate variability, and neurobehavioral scales.

Why it matters

Who can join: the full rules

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

Where it's running

• Stony Brook University Hospital
  Stony Brook, New York, United States Recruiting

Study contacts

• Study coordinator: Sima Mofakham, PhD
• Email: sima.mofakham@stonybrookmedicine.edu
• Phone: 631-444-1278

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.