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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
DeviceThis 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).
Treatment groups
Trial outcomes
Primary outcomes
Survey nursing attitudes towards daily tAN and the compatibility of tAN with standard patient care activities in the ICU; Examine the safety of tAN in ICU patients.
Registered nurses providing direct care to ICU patients receiving tAN will be asked to complete the Sparrow Ascent ICU User Acceptance Questionnaire to assess the compatibility of tAN with patient care.
Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients.
Every effort will be made to initiate tAN as soon after injury as possible in order to capture early postinjury data on the effectiveness of tAN and to inform the design of future studies.
Explore the effect of tAN on Blood Pressure
Blood pressure (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN
Explore the effect of tAN on Heart Rate
Heart rate (bpm) will be checked twice daily, pre-tAN and 30 minutes post-tAN
Sponsors and contacts
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