NCT Number: NCT07510074
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
University Hospital, San Antonio, Texas, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Patients will have the device placed on their tragus and will receive a low level of stimulation that tapers to zero over 30 seconds.
Time frame: Baseline to study end (approximately 7 days)
Frequency of adverse events related to tsVNS will be assessed through systematic monitoring
Time frame: Baseline
Proportion of eligible patients who consent to participate in the study, protocol adherence, and device tolerability.
Time frame: Baseline to study end (approximately 7 days)
Blood tests will be performed to provide IL-6 levels
Time frame: Baseline to study end (approximately 7 days)
Blood tests will be performed to provide GFAP levels
Time frame: Baseline to study end (approximately 7 days)
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.
Contact information is provided by the study sponsor or research team.
Michael McGinity, MD
CONTACT
Patrick Thompson
CONTACT
The University of Texas Health Science Center at San Antonio
Other
MINT: Modulating Inflammation in Neuro-Trauma
Acronym: MINT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07722702
Brain Diseases, Brain Edema
Banhā, Qalyobia, Egypt
View Trial DetailsNCT03243539
Acute Brain Injury, Anoxic Brain Injury
Murray, Utah, United States
View Trial DetailsNCT04117672
Brain Diseases, Brain Edema
Lund, Sweden
View Trial DetailsNCT03098459
Alzheimer Disease, Alzheimer; Early Onset
Nashville, Tennessee, United States
View Trial Details