Modulating Inflammation in Neuro-Trauma

NCT07510074 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00002468
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

Vagus nerve stimulation (VNS); Inflammation; Cerebral edema

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Interleuken-6 (IL-6) Biomarker Level

  Baseline to study end (approximately 7 days)

• Change in Glial fibrillary acidic protein (GFAP) levels

  Baseline to study end (approximately 7 days)

• Extended Glasgow Outcome Scale

  Baseline to study end (approximately 7 days)

Study Arms (2)

Treatment group taVNS

EXPERIMENTAL

Treatment with transauricular vagus nerve stimulation (taVNS) after admission to trauma with a traumatic brain injury (TBI)

Device: Nurosym taVNS

Control group

SHAM COMPARATOR

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)

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.

Also known as: Vagal nerve stimulator

Treatment group taVNS

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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Parasym Ltd.: collaborator

Study Sites (2)

University Hospital

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Inflammation; Brain Edema

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael McGinity, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Thompson

CONTACT

817-807-6006; thompsonp4@livemail.uthscsa.edu

Michael McGinity, MD

CONTACT

210 567 5823; McGinity@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind design with participants (when cognitively able), outcome assessors, clinical teams, and laboratory personnel blinded to treatment assignment. Unblinded study personnel will program devices but not assess outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single-site, prospective, randomized, double-blind, sham-controlled pilot trial

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: April 3, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At study completion after data analysis are complete and a publication is accepted to a journal.

Locations

US (2)