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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Parkland Health & Hospital System
  Dallas, Texas, United States Recruiting
• 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
• Email: alex.valadka@utsouthwestern.edu
• Phone: 2146452300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.