Auricular Neurostimulation for Traumatic Brain Injury
(tAN-TBI Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAlex Valadka, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for ICU patients with traumatic brain injury (TBI). It's aimed at those who can safely undergo neurostimulation therapy. Details on specific inclusion and exclusion criteria are not provided, but typically these would outline the severity of TBI, age range, and any other health conditions that might affect patient safety or the results of the study.

Inclusion Criteria

My GCS score was 12 or lower after being resuscitated and I have trauma-related bleeding in my brain.

I am 18 years old or older.

Consent from legally authorized representative

Exclusion Criteria

Expected imminent mortality because of overwhelming neurological and/or systemic injury

My neurological status is unclear due to medication or substance use.

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

+4 more

Participant Groups

The trial is testing a device called Sparrow Ascent which provides transcutaneous auricular neurostimulation (tAN) to see if it's safe for use in ICU patients with TBI and to observe its effects on inflammation markers, blood pressure, heart rate, intracranial pressure (ICP), and neurological function.

1Treatment groups

Experimental Treatment

Group I: Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patientsExperimental Treatment1 Intervention

Subjects will receive treatment upon providing informed consent and will undergo transcutaneous auricular neurostimulation (tAN) once daily during their ICU stay, with the treatment duration not exceeding 10 days. Two blood samples will be collected daily: one before the tAN session and another two hours after the session. Participant data will be collected daily throughout the ICU stay. Additionally, surveys will be collected from registered nurses providing direct care to TBI patients enrolled in the tAN-TBI study to assess the compatibility of tAN with patient care processes in the ICU.