Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

NCT ID: NCT06467708

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-11
• Study Completion Date: 2027-02-11

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.

Conditions

TBI (Traumatic Brain Injury)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

Intervention Type: DEVICE

This method of simultaneous vagal and trigeminal stimulation via the external ear is known as transcutaneous auricular neurostimulation (tAN), as the targets of electrical stimulation include the auricular branch of the vagus nerve (ABVN) and auriculotemporal nerve (ATN), which is a branch of the mandibular division of the trigeminal nerve. Electrodes applied to select dermatome regions can target ear neural structures and deliver non-invasive vagus nerve stimulation (VNS) and trigeminal nerve stimulation (TNS).

Interventions

Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

This method of simultaneous vagal and trigeminal stimulation via the external ear is known as transcutaneous auricular neurostimulation (tAN), as the targets of electrical stimulation include the auricular branch of the vagus nerve (ABVN) and auriculotemporal nerve (ATN), which is a branch of the mandibular division of the trigeminal nerve. Electrodes applied to select dermatome regions can target ear neural structures and deliver non-invasive vagus nerve stimulation (VNS) and trigeminal nerve stimulation (TNS).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alex Valadka

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alex Valadka, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2024-0360

Identifier Type: -

Identifier Source: org_study_id