Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Post-resuscitation GCS score 12 or below and acute trauma-related intradural blood on head CT scan after TB

Age 18 years or older (pediatric trauma patients are not routinely transported to Parkland)

Consent from legally authorized representative

Disqualifiers

Hemodynamic instability

Expected imminent mortality because of overwhelming neurological and/or systemic injury

Unclear neurological status because of paralytic medications or intoxication with ethanol or other drugs

Presence of other electrical stimulation devices (pacemaker, cochlear prosthesis, neurostimulator, etc.)

Trial design

Treatments tested in this trial

  • Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

Treatment groups

42 Participants
are divided into 1 treatment group