Nurosym taVNS for Traumatic Brain Injury
(MINT Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Michael McGinity, MD
Principal Investigator
The University of Texas Health Science Center at San Antonio
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active taVNS or sham stimulation twice daily with periodic blood draws
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of functional outcome using the Extended Glasgow Outcome Scale at hospital discharge
What Are the Treatments Tested in This Trial?
Interventions
- Nurosym (sham)
- Nurosym taVNS
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Treatment with transauricular vagus nerve stimulation (taVNS) after admission to trauma with a traumatic brain injury (TBI)
The control group will undergo sham stimulation using the same device placed at the same location with a brief, low level stimulation that tapers over 30 seconds.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
Parasym Ltd.
Industry Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.