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โ† Trials
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Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

RecruitingNAAges 18 Years - anyAllUniversity of Texas Southwestern Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
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Where

2 sites
Parkland Health & Hospital System
Dallas, United States
UT Southwestern Medical Center
Dallas, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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