NCT06467708 · University of Texas Southwestern Medical Center
Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury
(tAN-TBI)
What this study is about
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.
View original scientific 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
DEVICE
Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
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).
Primary outcome measures
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.
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.
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.
Time frame: TBI patients will receive tAN stimulation once per day and will not exceed 10 days.
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
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.
Blood pressure (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN
Explore the effect of tAN on Heart Rate
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.
Heart rate (bpm) will be checked twice daily, pre-tAN and 30 minutes post-tAN
Explore the effect of tAN on Respiratory Rate (and ventilator settings and use of noninvasive oxygenation and ventilation if applicable)
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.
Respiratory rate (bpm) will be checked twice daily, pre-tAN and 30 minutes post-tAN
Explore the effect of tAN on Temperature
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.
Temperature (°C/°F) will be checked twice daily, pre-tAN and 30 minutes post-tAN
Explore the effect of tAN on Intracranial pressure
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.
Intracranial pressure (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN
Explore the effect of tAN on Brain Tissue Oxygen Tension (PbtO2)
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.
Brain Tissue Oxygen Tension (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN
Explore the effect of tAN on Glasgow Coma Scale (GCS) (and any sedatives or analgesics that could affect neurological assessment)
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.
GCS (and any sedatives or analgesics that could affect neurological assessment) will be checked twice daily, pre-tAN and 30 minutes post-tAN. Scale from 3 to 15, where 3 represents deep unconsciousness and 15 indicates full consciousness.
Explore the effect of tAN on Pupillary Diameter
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.
Pupillary Diameter (mm) will be checked twice daily, pre-tAN and 30 minutes post-tAN
Explore the effect of tAN on Neurological Pupil index (NPi) via pupillometry
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.
Neurological Pupil index (NPi) via pupillometry dimensionless index, typically ranging from 0 to 5. This will be checked twice daily, pre-tAN and 30 minutes post-tAN
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.)
- Abnormal ear anatomy or ear infection
- Participant is pregnant or lactating
- 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
Where
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations