Study of Dual-Site Ear Nerve Stimulation for Consciousness Recovery After Severe Traumatic Brain Injury

What this Trial Is About

Researchers are evaluating a new non-invasive treatment involving dual-site auricular nerve stimulation to help patients with severe traumatic brain injury who are unable to respond but may still be aware, a condition called cognitive motor dissociation. This pilot study aims to assess the safety and effectiveness of stimulating the vagus and trigeminal nerves together, which have individually shown potential in aiding recovery of consciousness. The study is open-label, single-arm, and conducted at a single center involving patients admitted to neurology or neurosurgical ICUs. Participants receive daily one-hour sessions of nerve stimulation delivered through ear-clip electrodes on the left ear, targeting both vagal inner ear and trigeminal outer ear nerve sites with specific electrical parameters. The treatment course lasts for 7 consecutive days, with possible extension up to 28 days. During sessions, continuous heart and oxygen monitoring, pain assessment, and nerve stimulation adjustments ensure safety. The stimulation device used is FDA-cleared and operated under investigational protocol. Throughout the study, participants undergo baseline and daily assessments including the Coma Recovery Scale-Revised CRS-R, Glasgow Coma Scale, vital signs, EEG, and nociception scoring. An automated camera system called SeeMe detects subtle voluntary motor responses during stimulation. Researchers monitor changes in consciousness, motor responses, and any device-related adverse events. The total participation lasts up to 28 days, with continuous safety monitoring and evaluation guiding future research.

Vagus Nerve Stimulation in Patients in Comatose State