Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury
This study is looking at a device called Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) for patients in the intensive care unit (ICU) who have had a traumatic brain injury (TBI). The tAN device stimulates nerves in the ear. Researchers want to see if tAN is safe and practical to use in the ICU, and how nurses feel about using it. They will also measure how tAN affects inflammation in the body and explore its impact on blood pressure. You might be able to join if you are 18 or older, have a TBI with a certain score on the Glasgow Coma Scale (GCS), and a legally authorized representative can give consent for you. The study aims to enroll 42 participants, but its current status is unclear.
- Study design
- This is a single-center, open-label study without randomization, involving up to 42 participants.
- What's involved
- You would receive tAN stimulation once a day for up to 10 days. Blood samples would be collected before and after stimulation, and vital signs recorded twice daily.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your blood pressure data will be collected for up to 10 days, or until you are discharged from the hospital.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Alex Valadka, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
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What this trial measures
- Survey nursing attitudes towards daily tAN and the compatibility of tAN with standard patient care activities in the ICU; Examine the safety of tAN in ICU patients.Registered nurses can complete the Sparrow Ascent ICU User Acceptance Questionnaire at Day 1- Day 10, or before the TBI patient is discharged from the hospital, or ICU. It may not be completed on Day 11 or after the patient has been discharged.
Registered nurses providing direct care to ICU patients receiving tAN will be asked to complete the Sparrow Ascent ICU User Acceptance Questionnaire to assess the compatibility of tAN with patient care.
- Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients.TBI patients will receive tAN stimulation once per day and will not exceed 10 days.
Every effort will be made to initiate tAN as soon after injury as possible in order to capture early postinjury data on the effectiveness of tAN and to inform the design of future studies.
- Explore the effect of tAN on Blood PressureData 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.
Blood pressure (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN
- Explore the effect of tAN on Heart RateData 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.
Heart rate (bpm) will be checked twice daily, pre-tAN and 30 minutes post-tAN
- Explore the effect of tAN on Respiratory Rate (and ventilator settings and use of noninvasive oxygenation and ventilation if applicable)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.
Respiratory rate (bpm) will be checked twice daily, pre-tAN and 30 minutes post-tAN
- Explore the effect of tAN on TemperatureData 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.
Temperature (°C/°F) will be checked twice daily, pre-tAN and 30 minutes post-tAN
- Explore the effect of tAN on Intracranial pressureData 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.
Intracranial pressure (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN
- Explore the effect of tAN on Brain Tissue Oxygen Tension (PbtO2)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.
Brain Tissue Oxygen Tension (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN
- Explore the effect of tAN on Glasgow Coma Scale (GCS) (and any sedatives or analgesics that could affect neurological assessment)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.
GCS (and any sedatives or analgesics that could affect neurological assessment) will be checked twice daily, pre-tAN and 30 minutes post-tAN. Scale from 3 to 15, where 3 represents deep unconsciousness and 15 indicates full consciousness.
- Explore the effect of tAN on Pupillary DiameterData 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.
Pupillary Diameter (mm) will be checked twice daily, pre-tAN and 30 minutes post-tAN
- Explore the effect of tAN on Neurological Pupil index (NPi) via pupillometryData 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.
Neurological Pupil index (NPi) via pupillometry dimensionless index, typically ranging from 0 to 5. This will be checked twice daily, pre-tAN and 30 minutes post-tAN