Health TrialsbyHealthPanel

Modulating Inflammation in Neuro-Trauma

ConditionTraumatic Brain Injury
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Nurosym taVNS

    Device

    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.

  • Nurosym (sham)

    Device

    Patients will have the device placed on their tragus and will receive a low level of stimulation that tapers to zero over 30 seconds.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Treatment group taVNSExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Adverse Events

Frequency of adverse events related to tsVNS will be assessed through systematic monitoring

Time frame
Baseline to study end (approximately 7 days)
2

Feasibility of recruitment

Proportion of eligible patients who consent to participate in the study, protocol adherence, and device tolerability.

Time frame
Baseline

Secondary outcomes

1

Change in Interleuken-6 (IL-6) Biomarker Level

Blood tests will be performed to provide IL-6 levels

Time frame
Baseline to study end (approximately 7 days)
2

Change in Glial fibrillary acidic protein (GFAP) levels

Blood tests will be performed to provide GFAP levels

Time frame
Baseline to study end (approximately 7 days)
3

Extended Glasgow Outcome Scale

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.

Time frame
Baseline to study end (approximately 7 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

Parasym Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: