Clinical trial NCT06467708: Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury
Official title: Delivering Transcutaneous Auricular Neurostimulation (tAN) to ICU Patients With Traumatic Brain Injury (tAN-TBI)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Keywords: Transcutaneous auricular neurostimulation (tAN)
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: TBI patients in the ICU with Glasgow Coma Scale score of 12 or below and acute traumatic intradural blood on head CT
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a single-center, open-label, nonrandomized investigation. TBI patients with a post resuscitation Glasgow Coma Scale (GCS) score of 12 or less (commonly described as moderate or severe TBI) and acute traumatic intradural blood on head CT scan will be screened upon admission to the ICU at Parkland Memorial Hospital. It is expected that all or almost all subjects will be in the Neuroscience or Surgical ICU. Consent for participation will be sought from the subject's legally authorized representative. Exception from informed consent or waiver of consent will not be part of this study.

tAN will begin as soon as feasible after subject enrollment. Immediately prior to this intervention, vital signs, neurologic status, and other clinical parameters will be recorded, and pre-tAN blood will be collected for measurement of serum inflammatory markers. tAN will be administered for 30 minutes under the supervision of a member of the research team. After 30 minutes (just prior to stopping tAN), the same clinical parameters that were recorded at baseline will again be recorded then tAN will be stopped. Approximately two hours after tAN has ended, a post-tAN blood sample will be collected for measurement of the same inflammatory markers as in the pre-tAN blood sample. At each timepoint for blood collection, additional blood may be collected for banking and future analyses.

Patients will undergo research blood draws and tAN stimulation for a maximum of 10 days. Research-related procedures will not exceed this 10-day period.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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.
measure: Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients.
timeFrame: TBI patients will receive tAN stimulation once per day and will not exceed 10 days.
measure: Explore the effect of tAN on Blood Pressure
timeFrame: 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.
measure: Explore the effect of tAN on Heart Rate
timeFrame: 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.
measure: Explore the effect of tAN on Respiratory Rate (and ventilator settings and use of noninvasive oxygenation and ventilation if applicable)
timeFrame: 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.
measure: Explore the effect of tAN on Temperature
timeFrame: 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.
measure: Explore the effect of tAN on Intracranial pressure
timeFrame: 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.
measure: Explore the effect of tAN on Brain Tissue Oxygen Tension (PbtO2)
timeFrame: 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.
measure: Explore the effect of tAN on Glasgow Coma Scale (GCS) (and any sedatives or analgesics that could affect neurological assessment)
timeFrame: 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.
measure: Explore the effect of tAN on Pupillary Diameter
timeFrame: 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.
measure: Explore the effect of tAN on Neurological Pupil index (NPi) via pupillometry
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Alex Valadka, MD
role: PRINCIPAL_INVESTIGATOR
References: