Modulating Inflammation in Neuro-Trauma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nurosym taVNS, Nurosym (sham).
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MINT: Modulating Inflammation in Neuro-Trauma
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Number of Adverse Events [Time frame: Baseline to study end (approximately 7 days)]
- Feasibility of recruitment [Time frame: Baseline]
Secondary outcome measures (3)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University Hospital — San Antonio
- University of Texas Health Science Center at San Antonio — San Antonio
Identifiers
NCT: NCT07510074 · STUDY00002468