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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Adverse Events
Timeframe: Baseline to study end (approximately 7 days)
Feasibility of recruitment
Timeframe: Baseline