Noninvasive ear-surface nerve stimulation for adults with traumatic brain injury in the ICU

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

This pilot tests whether brief, noninvasive ear-surface nerve stimulation is safe and changes inflammation markers in adults with moderate-to-severe traumatic brain injury in the ICU.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT06467708 on ClinicalTrials.gov

What this trial studies

This is a single-center, open-label, nonrandomized pilot enrolling adult ICU patients with post-resuscitation GCS ≤12 and acute intradural blood on head CT. Participants receive 30 minutes of transcutaneous auricular neurostimulation (tAN) under research supervision, with pre- and post-stimulation blood draws to measure serum inflammatory markers and physiologic parameters. Stimulation and research blood draws may be repeated daily for up to 10 days while the patient remains in the ICU, and additional samples may be banked for future analyses. Consent is obtained from the legally authorized representative prior to any research procedures.

Who should consider this trial

Good fit: Adults (age ≥18) with moderate-to-severe TBI (post-resuscitation GCS ≤12) and acute traumatic intradural blood on head CT who are admitted to the ICU and can be enrolled via a legally authorized representative.

Not a fit: Patients who are hemodynamically unstable, expected to die imminently, have other implanted electrical devices, abnormal ear anatomy or infection, or who are pregnant/lactating are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could reduce inflammatory signals and improve physiological stability or neurologic recovery after acute TBI.

How similar studies have performed: Early studies of auricular neurostimulation in other settings have shown signals of autonomic and inflammatory modulation, but application in acute TBI is novel and has not been validated at scale.

Eligibility criteria

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

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Alex Valadka, MD — University of Texas Southwestern Medical Center
• Study coordinator: Alex Valadka, MD

Conditions: TBI, Transcutaneous auricular neurostimulation