Modulating Inflammation in Neuro-Trauma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe University of Texas Health Science Center at San Antonio

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

16 Participants
are divided into 2 treatment groups

Sponsors and collaborators