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NCT Number: NCT06467708

Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

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.

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Key information

Conditions

TBI (Traumatic Brain Injury) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This is a single-center, open-label, nonrandomized investigation. TBI patients with a post resuscitation Glasgow Coma Scale (GCS) score of 12 or less (commonly described as moderate or severe TBI) and acute traumatic intradural blood on head CT scan will be screened upon admission to the ICU at Parkland Memorial Hospital. It is expected that all or almost all subjects will be in the Neuroscience or Surgical ICU. Consent for participation will be sought from the subject's legally authorized representative. Exception from informed consent or waiver of consent will not be part of this study.

tAN will begin as soon as feasible after subject enrollment. Immediately prior to this intervention, vital signs, neurologic status, and other clinical parameters will be recorded, and pre-tAN blood will be collected for measurement of serum inflammatory markers. tAN will be administered for 30 minutes under the supervision of a member of the research team. After 30 minutes (just prior to stopping tAN), the same clinical parameters that were recorded at baseline will again be recorded then tAN will be stopped. Approximately two hours after tAN has ended, a post-tAN blood sample will be collected for measurement of the same inflammatory markers as in the pre-tAN blood sample. At each timepoint for blood collection, additional blood may be collected for banking and future analyses.

Patients will undergo research blood draws and tAN stimulation for a maximum of 10 days. Research-related procedures will not exceed this 10-day period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

    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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Aisha Qureshi

CONTACT

[email protected]

2146489905

Alex Valadka, MD

CONTACT

[email protected]

2146452300

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Delivering Transcutaneous Auricular Neurostimulation (tAN) to ICU Patients With Traumatic Brain Injury (tAN-TBI)

Acronym: tAN-TBI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 21, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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