What this study is
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.
What's being tested
- Nurosym taVNS
Intervention · DEVICE
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.
- Nurosym (sham)
Intervention · DEVICE
Patients will have the device placed on their tragus and will receive a low level of stimulation that tapers to zero over 30 seconds.
Study details
- Official title
- MINT: Modulating Inflammation in Neuro-Trauma
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Conditions
- Traumatic Brain Injury
- Enrolling
- 16 people
- Starts
- 2026-11
- Est. completion
- 2027-07
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity Hospital
San Antonio, Texas, United States
- Patrick Thompson · Contact8178076006thompsonp4@livemail.uthscsa.edu
- Michael McGinity, MD · Contact210 567 5823McGinity@uthscsa.edu
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Study team
Sponsor
The University of Texas Health Science Center at San Antonio
Study ID STUDY00002468
Principal investigator
Michael McGinity, MD
The University of Texas Health Science Center at San Antonio
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.