Modulating Inflammation in Neuro-Trauma (NCT07510074) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Modulating Inflammation in Neuro-Trauma
United States16 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Adverse Events
Timeframe: Baseline to study end (approximately 7 days)
2
Feasibility of recruitment
Timeframe: Baseline
Trial details
NCT IDNCT07510074
SponsorThe University of Texas Health Science Center at San Antonio