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Modulating Inflammation in Neuro-Trauma

Study acronym: MINT
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jan 2027 → Jul 2027
See other at-risk trials from The University of Texas Health Science Center at San Antonio

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Start date: Aug 2026 to Nov 2026 Show 4 more changesShow less
    • Primary completion pushed from Jan 2027 to Jul 2027
    • Study completion pushed from Mar 2027 to Jul 2027
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Notable Start date: May 2026 to Aug 2026v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07510074
Lead Sponsor The University of Texas Health Science Center at San Antonio
Collaborators: Parasym Ltd.
Conditions
(from sponsor)
Traumatic Brain Injury
Related terms Brain Edema, Brain Injuries, Traumatic, Inflammation
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov