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Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

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

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

1. Post-resuscitation GCS score 12 or below and acute trauma-related intradural blood on head CT scan after TB
2. Age 18 years or older (pediatric trauma patients are not routinely transported to Parkland)
3. Consent from legally authorized representative

Exclusion Criteria:

1. Hemodynamic instability
2. Expected imminent mortality because of overwhelming neurological and/or systemic injury
3. Unclear neurological status because of paralytic medications or intoxication with ethanol or other drugs
4. Presence of other electrical stimulation devices (pacemaker, cochlear prosthesis, neurostimulator, etc.)
5. Abnormal ear anatomy or ear infection
6. Participant is pregnant or lactating
7. 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

About the study

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.

What is being tested

• Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) (device)

Sponsor: University of Texas Southwestern Medical Center · Participants: 42 · Started: Feb 11, 2025

Contact the study team

• Alex Valadka, MD · Phone: 2146452300
• Aisha Qureshi · Phone: 2146489905

Official record on ClinicalTrials.gov — NCT06467708

Locations in the U.S.

Conditions

• Traumatic Brain Injury

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.