NCT06467708 Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury
| NCT ID | NCT06467708 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | TBI (Traumatic Brain Injury) |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2027-02-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2025-02-11 with a primary completion date of 2027-02-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Alex Valadka, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06467708 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying TBI (Traumatic Brain Injury). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06467708 currently recruiting?
Yes, NCT06467708 is actively recruiting participants. Contact the research team at alex.valadka@utsouthwestern.edu for enrollment information.
Where is the NCT06467708 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06467708 clinical trial?
NCT06467708 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Alex Valadka, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 42 participants.