NCT07510074

Modulating Inflammation in Neuro-Trauma

MINT: Modulating Inflammation in Neuro-Trauma

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

MINT is a pilot randomized controlled trial designed to establish the safety and feasibility of taVNS in acute moderate to severe TBI prior to a larger efficacy trial. Sixteen patients with GCS 3-12 admitted to University Hospital, San Antonio will be randomized 1:1 to active taVNS or sham stimulation. Patients entering the University Hospital trauma bay who are diagnosed with traumatic brain injury (TBI) will be prescreened according to inclusion/exclusion criteria for entrance into this study. Participants will be randomized to receive either treatment with active taVNS or sham treatment. A blood draw will be performed prior to initiating auricular vagus nerve stimulation. Patients will undergo standard of care treatment according to attending physicians, and the investigators will continue taVNS treatment during the course of the patients' admissions. The control group will undergo sham stimulation using the same device placed at the same location. Both active and sham stimulations will be administered under the supervision of study staff, and both patients and treating clinicians will be blinded to group assignment. Patients will be stimulated twice daily with periodic blood draws for up to 7 days.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	Nurosym taVNS	Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that electrically stimulates the auricular branch of the vagus nerve via electrodes placed on the tragus of the ear.
DEVICE	Nurosym (sham)	Patients will have the device placed on their tragus and will receive a low level of stimulation that tapers to zero over 30 seconds.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study