About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Pregnant
Any electrical implanted device
Immunomodulatory medication
Human Immune Deficiency Virus (HIV) patients
Trial design
Treatments tested in this trial
- Nurosym taVNS
- Nurosym (sham)
Treatment groups
Sponsors and collaborators
The University of Texas Health Science Center at San Antonio
Lead sponsor
Parasym Ltd.
Collaborator