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.

NCT Number	NCT07510074
Lead Sponsor	The University of Texas Health Science Center at San Antonio Collaborators: Parasym Ltd.
Conditions	Traumatic Brain Injury
Enrollment	16 participants
Start Date	2026-08
Primary Completion	2027-01 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-07-17