Modulating Inflammation in Neuro-Trauma (MINT)

MINT: Modulating Inflammation in Neuro-Trauma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: Nurosym taVNS; Device: Nurosym (sham)

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Thompson; Phone Number: 817-807-6006; Email: thompsonp4@livemail.uthscsa.edu
• Study Contact Backup: Name: Michael McGinity, MD; Phone Number: 210 567 5823; Email: McGinity@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University Hospital
      • Contact: Michael McGinity, MD; Phone Number: 210 567 5823; Email: McGinity@uthscsa.edu
      • Contact: Patrick Thompson; Phone Number: 8178076006; Email: thompsonp4@livemail.uthscsa.edu
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group taVNS; Treatment with transauricular vagus nerve stimulation (taVNS) after admission to trauma with a traumatic brain injury (TBI)	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.; Other Names: Vagal nerve stimulator
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events	Frequency of adverse events related to tsVNS will be assessed through systematic monitoring	Baseline to study end (approximately 7 days)
Feasibility of recruitment	Proportion of eligible patients who consent to participate in the study, protocol adherence, and device tolerability.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Interleuken-6 (IL-6) Biomarker Level	Blood tests will be performed to provide IL-6 levels	Baseline to study end (approximately 7 days)
Change in Glial fibrillary acidic protein (GFAP) levels	Blood tests will be performed to provide GFAP levels	Baseline to study end (approximately 7 days)
Extended Glasgow Outcome Scale	The Glasgow Outcome Scale - Extended (GOS-E) is an 8-point ordinal scale assessing functional outcome following traumatic brain injury, ranging from 1 (death) to 8 (upper good recovery). It categorizes patients across levels of disability including vegetative state, severe disability, moderate disability, and good recovery, with each category subdivided into upper and lower levels. It will be administered at hospital discharge via structured interview.	Baseline to study end (approximately 7 days)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Parasym Ltd.
• Investigators: Principal Investigator: Michael McGinity, MD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Cerebral edema; Vagus nerve stimulation (VNS)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Pathological Conditions, Signs and Symptoms; Brain Injuries, Traumatic; Inflammation; Brain Edema
• Other Study ID Numbers: STUDY00002468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After primary publication, de-identified data may be shared with other researchers upon reasonable request, in accordance with NIH data sharing policies and procedures described in the informed consent document.
• IPD Sharing Time Frame: At study completion after data analysis are complete and a publication is accepted to a journal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes