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RECRUITING Not applicable ClinicalTrials.gov

Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

Sponsor: University of Texas Southwestern Medical Center • ClinicalTrials.gov ID: NCT06467708

Registry updated: 2026-09-30
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Description

The overarching goal of this pilot study is to assess the feasibility and safety of transcutaneous auricular neurostimulation (tan) in ICU patients with TBi and to determine the effect of tan on serum markers of inflammation. exploratory analyses will examine effects on such physiological parameters as blood pressure, heart rate, and intracranial pressure (iCP), as well as measures of neurological function.

Interventions

  • Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) (Device)
    This method of simultaneous vagal and trigeminal stimulation via the external ear is known as transcutaneous auricular neurostimulation (tAN), as the targets of electrical stimulation include the auricular branch of the vagus nerve (ABVN) and auriculotemporal nerve (ATN), which is a branch of the mandibular division of the trigeminal nerve. Electrodes applied to select dermatome regions can target ear neural structures and deliver non-invasive vagus nerve stimulation (VNS) and trigeminal nerve stimulation (TNS).

Eligibility criteria

Inclusion Criteria: 1. Post-resuscitation GCS score 12 or below and acute trauma-related intradural blood on head CT scan after TB 2. Age 18 years or older (pediatric trauma patients are not routinely transported to Parkland) 3. Consent from legally authorized representative Exclusion Criteria: 1. Hemodynamic instability 2. Expected imminent mortality because of overwhelming neurological and/or systemic injury 3. Unclear neurological status because of paralytic medications or intoxication with ethanol or other drugs 4. Presence of other electrical stimulation devices (pacemaker, cochlear prosthesis, neurostimulator, etc.) 5. Abnormal ear anatomy or ear infection 6. Participant is pregnant or lactating 7. Any other significant medical or psychosocial problems that, in the opinion of the investigator, would potentially cause harm to the participant, impact their ability to participate, or influence the results of the trial

Conditions

TBI (Traumatic Brain Injury)

Locations

  • Parkland Health & Hospital System — Dallas, Texas, United States
  • UT Southwestern Medical Center — Dallas, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record