Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury (NCT06467708)
Delivering Transcutaneous Auricular Neurostimulation (tAN) to ICU Patients With Traumatic Brain Injury (tAN-TBI)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (8 items).
Location: UT Southwestern Medical Center — Dallas, Texas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- UT Southwestern Medical Center — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (214) 645-2300
Email: alex.valadka@utsouthwestern.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All TBI (Traumatic Brain Injury) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.