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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Registered nurses can complete the Sparrow Ascent ICU User Acceptance Questionnaire at Day 1- Day 10, or before the TBI patient is discharged from the hospital, or ICU. It may not be completed on Day 11 or after the patient has been discharged.
2

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.

Time frame
TBI patients will receive tAN stimulation once per day and will not exceed 10 days.
3

Explore the effect of tAN on Blood Pressure

Blood pressure (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN

Time frame
Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.
4

Explore the effect of tAN on Heart Rate

Heart rate (bpm) will be checked twice daily, pre-tAN and 30 minutes post-tAN

Time frame
Data will be collected upon consent, twice daily from Day 1 to Day 10, or until the patient is discharged from the hospital. Data will not be collected past 10 days.

Secondary outcomes

Other outcomes

Sponsors and contacts

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