Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury
Recruiting now · Not applicable
Conditions studied: TBI (Traumatic Brain Injury)
In brief
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.
Key facts
- Study ID
- NCT06467708
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 42
- Starts
- 2025-02-11
- Expected to finish
- 2027-02-11
- Last updated by the study team
- 2026-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Post-resuscitation GCS score 12 or below and acute trauma-related intradural blood on head CT scan after TB
- Age 18 years or older (pediatric trauma patients are not routinely transported to Parkland)
- Consent from legally authorized representative
You may not qualify if…
- 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
Where it is running
- UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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