Modulating Inflammation in Neuro-Trauma

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07510074
Status
Not Yet Recruiting

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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Nurosym taVNS — 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) — 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

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.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group taVNS
    Treatment with transauricular vagus nerve stimulation (taVNS) after admission to trauma with a traumatic brain injury (TBI)
  • Sham Comparator: Control group
    The control group will undergo sham stimulation using the same device placed at the same location with a brief, low level stimulation that tapers over 30 seconds.

Primary Outcome Measure

Number of Adverse Events [ Time Frame: Baseline to study end (approximately 7 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University HospitalSan AntonioTexas78229
Patrick Thompson
[email protected]
8178076006
Michael McGinity, MD
[email protected]
210 567 5823
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-

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