Traumatic Brain InjuryMINTNCT07510074
Modulating Inflammation in Neuro-Trauma
A study testing Nurosym taVNS in people with Traumatic Brain Injury, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Nurosym taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant
- Any electrical implanted device
- Immunomodulatory medication
- Human Immune Deficiency Virus (HIV) patients
- Autoimmune disease
- Known cancer immunotherapy
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University Hospital
San Antonio, Texas, 78229
Patrick Thompson, 8178076006, thompsonp4@livemail.uthscsa.edu
Michael McGinity, MD, 210 567 5823, McGinity@uthscsa.edu
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Nurosym taVNS, Nurosym (sham)
- Keywords
- Vagus nerve stimulation (VNS), Inflammation, Cerebral edema
- Medical subject headings
- Brain Injuries, Traumatic, Inflammation, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurosym taVNSDevice
Also called Vagal nerve stimulator
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 group | Role | What they receive |
|---|---|---|
| Treatment group taVNS | Experimental | Treatment with transauricular vagus nerve stimulation (taVNS) after admission to trauma with a traumatic brain injury (TBI) Receives: 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. Receives: Device: Nurosym (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Frequency of adverse events related to tsVNS will be assessed through systematic monitoring
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
Change in Interleuken-6 (IL-6) Biomarker Level
Blood tests will be performed to provide IL-6 levels
Measured: Baseline to study end (approximately 7 days)
Change in Glial fibrillary acidic protein (GFAP) levels
Blood tests will be performed to provide GFAP levels
Measured: 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.
Measured: Baseline to study end (approximately 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-site, prospective, randomized, double-blind, sham-controlled pilot trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Parasym Ltd.
- Responsible party
- Principal investigator, Michael McGinity, The University of Texas Health Science Center at San Antonio
- Investigators
- Michael McGinity, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510074
- Sponsor's protocol ID
- STUDY00002468
- Acronym
- MINT
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINT: Modulating Inflammation in Neuro-Trauma
- ClinicalTrials.gov ID
- NCT07510074
- Acronym / sponsor ID
- MINT / STUDY00002468
- Conditions
- Traumatic Brain Injury
- Keywords
- Vagus nerve stimulation (VNS), Inflammation, Cerebral edema
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Parasym Ltd.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-site, prospective, randomized, double-blind, sham-controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group taVNS | Experimental | Device: Nurosym taVNSTreatment with transauricular vagus nerve stimulation (taVNS) after admission to trauma with a traumatic brain injury (TBI) |
| Control group | Sham comparator | Device: Nurosym (sham)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Pregnant
- Any electrical implanted device
- Immunomodulatory medication
- Human Immune Deficiency Virus (HIV) patients
- Autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurosym taVNSAlso: Vagal nerve stimulatorTranscutaneous 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. | Device | Treatment group taVNS |
| 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. | Device | Control group |
Primary outcome
Number of Adverse Events
Time frame: Baseline to study end (approximately 7 days)
Frequency of adverse events related to tsVNS will be assessed through systematic monitoring
Feasibility of recruitment
Time frame: Baseline
Proportion of eligible patients who consent to participate in the study, protocol adherence, and device tolerability.
3 secondary outcomes
Change in Interleuken-6 (IL-6) Biomarker Level
Time frame: Baseline to study end (approximately 7 days)
Change in Glial fibrillary acidic protein (GFAP) levels
Time frame: Baseline to study end (approximately 7 days)
Extended Glasgow Outcome Scale
Time frame: Baseline to study end (approximately 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael McGinity, MD principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurosym taVNS in people with Traumatic Brain Injury, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Thompson (817-807-6006, thompsonp4@livemail.uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: Baseline to study end (approximately 7 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.