Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury
NCT Number: NCT06467708
Acronym: tAN-TBI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: TBI (Traumatic Brain Injury)
Interventions: DEVICE: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)
Sponsor: University of Texas Southwestern Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2026-06
Locations: UT Southwestern Medical Center, Dallas, Texas, 75390, United States

Summary:
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.

Primary Outcome 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 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., 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.|Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients., 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., TBI patients will receive tAN stimulation once per day and will not exceed 10 days.|Explore the effect of tAN on Blood Pressure, Blood pressure (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN, 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.|Explore the effect of tAN on Heart Rate, Heart rate (bpm) will be checked twice daily, pre-tAN and 30 minutes post-tAN, 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.|Explore the effect of tAN on Respiratory Rate (and ventilator settings and use of noninvasive oxygenation and ventilation if applicable), Respiratory rate (bpm) will be checked twice daily, pre-tAN and 30 minutes post-tAN, 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.|Explore the effect of tAN on Temperature, Temperature (°C/°F) will be checked twice daily, pre-tAN and 30 minutes post-tAN, 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.|Explore the effect of tAN on Intracranial pressure, Intracranial pressure (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN, 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.|Explore the effect of tAN on Brain Tissue Oxygen Tension (PbtO2), Brain Tissue Oxygen Tension (mmHg) will be checked twice daily, pre-tAN and 30 minutes post-tAN, 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.|Explore the effect of tAN on Glasgow Coma Scale (GCS) (and any sedatives or analgesics that could affect neurological assessment), 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., 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.|Explore the effect of tAN on Pupillary Diameter, Pupillary Diameter (mm) will be checked twice daily, pre-tAN and 30 minutes post-tAN, 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.|Explore the effect of tAN on Neurological Pupil index (NPi) via pupillometry, 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, 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.