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)