Auricular Neurostimulation for Traumatic Brain Injury

(tAN-TBI Trial)

Overseen By Aisha Qureshi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Hemodynamic instability, Imminent mortality, Electrical devices, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 10 days

42 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) for Traumatic Brain Injury?

Research on similar treatments, like transcutaneous auricular vagus nerve stimulation (taVNS), shows potential benefits in consciousness recovery for patients with brain injuries. Studies indicate that taVNS can improve blood flow in the brain and may help restore consciousness in some patients. ^{1 2 3 4 5}

Is auricular neurostimulation safe for humans?

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe, with mild and temporary side effects like ear pain, headache, and tingling. A large review found no serious adverse events linked to taVNS, making it a safe option for clinical use. ^{1 2 6 7 8}

How is the treatment Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) unique for traumatic brain injury?

Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) is unique because it uses low-intensity electrical currents applied to the ear to stimulate the vagus nerve, which may help in consciousness recovery after traumatic brain injury. This approach is different from traditional treatments as it focuses on modulating the autonomic nervous system and improving cerebral blood flow, which are not typically targeted by other therapies. ^{1 2 3 4 5}

Research Team

Alex Valadka, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for ICU patients with traumatic brain injury (TBI). It's aimed at those who can safely undergo neurostimulation therapy. Details on specific inclusion and exclusion criteria are not provided, but typically these would outline the severity of TBI, age range, and any other health conditions that might affect patient safety or the results of the study.

Inclusion Criteria

My GCS score was 12 or lower after being resuscitated and I have trauma-related bleeding in my brain.

Consent from legally authorized representative

Exclusion Criteria

Expected imminent mortality because of overwhelming neurological and/or systemic injury

My neurological status is unclear due to medication or substance use.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Upon admission to ICU

1 visit (in-person)

Treatment

Participants receive transcutaneous auricular neurostimulation (tAN) once daily during their ICU stay, with blood samples collected before and after each session.

Up to 10 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of intracranial pressure, brain tissue oxygen tension, and other physiological parameters.

4 weeks

Treatment Details

Interventions

• Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)

Trial Overview The trial is testing a device called Sparrow Ascent which provides transcutaneous auricular neurostimulation (tAN) to see if it's safe for use in ICU patients with TBI and to observe its effects on inflammation markers, blood pressure, heart rate, intracranial pressure (ICP), and neurological function.

Participant Groups

Group I: Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

In a study involving 50 young adults, transcutaneous auricular nerve stimulation (taNS) at 130 µA significantly decreased cardiac output, with distinct gender-related responses observed: women experienced a drop in heart rate, while men showed reductions in stroke volume and contractility.

The findings suggest that the taNS protocol may have potential for modulating cardiac autonomic responses, but further research is needed to explore its therapeutic applications in various patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic responses to low-level transcutaneous auricular nerve stimulation in young volunteers. Šinkovec, M., Trobec, R., Kamenski, T., et al.[2023]

This study will evaluate the effectiveness and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in 90 patients with Disorders of Consciousness (DoC) due to traumatic brain injury, using various assessment methods including the Coma Recovery Scale-Revised (CRS-R) and brain imaging techniques over a 40-day intervention period.

The research aims to clarify the mechanism of taVNS in promoting consciousness recovery and will also monitor adverse effects, making it a comprehensive approach to understanding this non-invasive treatment's potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of transcutaneous auricular vagus nerve stimulation on patients with disorders of consciousness: A study protocol. Cheng, L., Sun, L., Xu, L., et al.[2023]

Transcutaneous auricular Vagus Nerve Stimulation (taVNS) can be optimized by varying electrode designs, which significantly affects the sensitivity and selectivity of nerve activation in different regions of the ear, as shown through a detailed anatomical model and finite element analysis.

The study found that smaller electrodes increase the electric field strength for a given current, allowing for more targeted stimulation of specific ear regions, which is crucial for enhancing the efficacy of taVNS in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). Kreisberg, E., Esmaeilpour, Z., Adair, D., et al.[2023]

Auricular stimulation (AS) has been shown to significantly reduce heart rate (HR) and alter heart rate variability (HRV) by decreasing the LF/HF ratio, indicating increased vagal activity, based on a systematic review of 78 trials.

The reduction in HR from AS is considered clinically safe, with only minor side effects reported, suggesting potential for further research into its use for managing conditions like tachycardia or autonomic imbalance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular effects of auricular stimulation -a systematic review and meta-analysis of randomized controlled clinical trials. Hua, K., Cummings, M., Bernatik, M., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and effective neuromodulation therapy for a variety of conditions, including epilepsy, depression, and anxiety, indicating its broad therapeutic potential.

Despite its effectiveness, there is currently no standardization among taVNS devices, and further research is needed to clarify the relationship between stimulation parameters and therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Wang, L., Wang, Y., Wang, Y., et al.[2022]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Hemodynamic responses to low-level transcutaneous auricular nerve stimulation in young volunteers. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Randomized trial of transcutaneous auricular vagus nerve stimulation on patients with disorders of consciousness: A study protocol. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Cerebral Hemodynamic Correlates of Transcutaneous Auricular Vagal Nerve Stimulation in Consciousness Restoration: An Open-Label Pilot Study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiovascular effects of auricular stimulation -a systematic review and meta-analysis of randomized controlled clinical trials. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]