An interventional study of Nurosym taVNS and Nurosym (sham) in Traumatic Brain Injury, sponsored by The University of Texas Health Science Center at San Antonio. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment
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.
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.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 16 is below the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment with transauricular vagus nerve stimulation (taVNS) after admission to trauma with a traumatic brain injury (TBI)
Device: Nurosym taVNS
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)
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
Patients will have the device placed on their tragus and will receive a low level of stimulation that tapers to zero over 30 seconds.
Number of Adverse Events
Frequency of adverse events related to tsVNS will be assessed through systematic monitoring
Time frame: 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.
Time frame: Baseline
Change in Interleuken-6 (IL-6) Biomarker Level
Blood tests will be performed to provide IL-6 levels
Time frame: Baseline to study end (approximately 7 days)
Change in Glial fibrillary acidic protein (GFAP) levels
Blood tests will be performed to provide GFAP levels
Time frame: 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.
Time frame: Baseline to study end (approximately 7 days)
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: At study completion after data analysis are complete and a publication is accepted to a journal.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.
Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's planned 8 months is below that.
Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 5, 2026: start Aug 2026 → Nov 2026, primary completion Jan 2027 → Jul 2027 and completion Mar 2027 → Jul 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio →