Clinical Research Directory
Browse clinical research sites, groups, and studies.
Modulating Inflammation in Neuro-Trauma
Sponsor: The University of Texas Health Science Center at San Antonio
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.
Official title: MINT: Modulating Inflammation in Neuro-Trauma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2026-05
Completion Date
2027-03
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (2)
University Hospital
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States