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Device

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

N/A

Waitlist Available

Led By Alex Valadka, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Post-resuscitation GCS score 12 or below and acute trauma-related intradural blood on head CT scan after TB

Be older than 18 years old

Must not have

Abnormal ear anatomy or ear infection

Hemodynamic instability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up data will be collected upon consent, twice daily from day 1 to day 10, or until the patient is discharged from the hospital. data will not be collected past 10 days.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using a type of ear stimulation called transcutaneous auricular neurostimulation (TAN) is safe and possible for patients in the ICU with traumatic brain injuries. They

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed; however, since this is a feasibility and safety study of tAN in critically ill patients with TBI, potential side effects may include skin irritation at the stimulation site or changes in vital signs like blood pressure or heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an ear infection or my ear's shape is unusual.

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My blood pressure and heart rate are stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ data will be collected upon consent, twice daily from day 1 to day 10, or until the patient is discharged from the hospital. data will not be collected past 10 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~data will be collected upon consent, twice daily from day 1 to day 10, or until the patient is discharged from the hospital. data will not be collected past 10 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and data will be collected upon consent, twice daily from day 1 to day 10, or until the patient is discharged from the hospital. data will not be collected past 10 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients.

Explore the effect of tAN on Blood Pressure

Explore the effect of tAN on Brain Tissue Oxygen Tension (PbtO2)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met