Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

NCT06467708 | Recruiting FDA Device

• 1 other identifier: STU-2024-0360
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

Transcutaneous auricular neurostimulation (tAN)

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

• 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.

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

• Explore the effect of tAN on Blood Pressure

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

  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.

• Explore the effect of tAN on Heart Rate

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

  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.

• Explore the effect of tAN on Respiratory Rate (and ventilator settings and use of noninvasive oxygenation and ventilation if applicable)

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

  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.

• Explore the effect of tAN on Temperature

  Temperature (°C/°F) will be checked twice daily, pre-tAN and 30 minutes post-tAN

  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.

• Explore the effect of tAN on Intracranial pressure

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

  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.

• Explore the effect of tAN on Brain Tissue Oxygen Tension (PbtO2)

  Brain Tissue Oxygen Tension (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN

  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.

• Explore the effect of tAN on Glasgow Coma Scale (GCS) (and any sedatives or analgesics that could affect neurological assessment)

  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.

  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.

• Explore the effect of tAN on Pupillary Diameter

  Pupillary Diameter (mm) will be checked twice daily, pre-tAN and 30 minutes post-tAN

  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.

• Explore the effect of tAN on Neurological Pupil index (NPi) via pupillometry

  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

  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.

Study Arms (1)

Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients

EXPERIMENTAL

Subjects will receive treatment upon providing informed consent and will undergo transcutaneous auricular neurostimulation (tAN) once daily during their ICU stay, with the treatment duration not exceeding 10 days. Two blood samples will be collected daily: one before the tAN session and another two hours after the session. Participant data will be collected daily throughout the ICU stay. Additionally, surveys will be collected from registered nurses providing direct care to TBI patients enrolled in the tAN-TBI study to assess the compatibility of tAN with patient care processes in the ICU.

Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

Interventions

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).

Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Alex Valadka, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Valadka, MD

CONTACT

2146452300; alex.valadka@utsouthwestern.edu

Aisha Qureshi

CONTACT

2146489905; Aisha.Qureshi@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: TBI patients in the ICU with Glasgow Coma Scale score of 12 or below and acute traumatic intradural blood on head CT

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 21, 2024
• Study Start: February 11, 2025
• Primary Completion (Estimated): February 11, 2027
• Study Completion (Estimated): February 11, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)