Traumatic Brain Injury
Conditions
Keywords
Vagus nerve stimulation (VNS), Inflammation, Cerebral edema
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.
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
DEVICENurosym 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.
DEVICENurosym (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.
Sponsors
The University of Texas Health Science Center at San Antonio
Parasym Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Single-site, prospective, randomized, double-blind, sham-controlled pilot trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | Baseline to study end (approximately 7 days) | Frequency of adverse events related to tsVNS will be assessed through systematic monitoring |
| Feasibility of recruitment | Baseline | Proportion of eligible patients who consent to participate in the study, protocol adherence, and device tolerability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interleuken-6 (IL-6) Biomarker Level | Baseline to study end (approximately 7 days) | Blood tests will be performed to provide IL-6 levels |
| Change in Glial fibrillary acidic protein (GFAP) levels | Baseline to study end (approximately 7 days) | Blood tests will be performed to provide GFAP levels |
| Extended Glasgow Outcome Scale | 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. |
Countries
United States
Contacts
CONTACTPatrick Thompson
CONTACTMichael McGinity, MD
PRINCIPAL_INVESTIGATORMichael McGinity, MD
The University of Texas Health Science Center at San Antonio
Outcome results
None listed