Modulating Inflammation in Neuro-Trauma

MINT is a single-site, prospective, randomized, double-blind, sham-controlled pilot trial evaluating the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with moderate to severe traumatic brain injury (GCS 3-12). Participants will be randomized to receive either active taVNS or sham stimulation using the same device. The primary objective is to assess the safety and feasibility of taVNS implementation in the acute TBI setting. Secondary objectives include exploratory measurement of serum inflammatory and neuronal injury biomarkers and assessment of functional outcome using the Extended Glasgow Outcome Scale at hospital discharge.

Inclusion Criteria: * Age 18-75 years old * Glasgow Coma Scale (GCS) Score 3-12 * Expected Intensive Care Unit (ICU) stay \> 48 hours * Presenting with acute Traumatic Brain Injury (TBI) within 24 hours Exclusion Criteria: * Pregnant * Any electrical implanted device * Immunomodulatory medication * Human Immune Deficiency Virus (HIV) patients * Autoimmune disease * Known cancer immunotherapy * Past medical history of symptomatic bradycardia * Penetrating brain injury * Clinical team assessment of prognosis and imminent risk of death such as Decision to withdraw life-sustaining measures * Current incarceration * Trauma/Laceration to the left ear