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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) for patients with traumatic brain injury (TBI) in the ICU. Researchers aim to determine the safety of this treatment and its effects on inflammation levels in the blood. They also examine its impact on blood pressure, heart rate, and brain pressure. This trial suits patients who have recently experienced a TBI, have a specific type of brain bleeding, and are currently in an ICU setting. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to new treatment options for TBI.

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 prior data suggests that transcutaneous auricular neurostimulation is safe for ICU patients with traumatic brain injury?

Research has shown that transcutaneous auricular neurostimulation (tAN) is generally safe. It has been used to assist with opioid withdrawal and received FDA approval for that purpose, indicating it has been tested and found safe for those cases.

Studies indicate that tAN is a non-invasive treatment, meaning it doesn't require surgery, and it usually only causes mild side effects. Some people might experience temporary ear pain or headaches, but these effects are not serious.

Overall, safety data from its use in other conditions suggest that tAN is well-tolerated. This information should reassure participants about its safety in the study on patients with traumatic brain injury (TBI). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for traumatic brain injury, which typically involves medication and supportive care, the Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN) offers a non-invasive approach by using electrical stimulation of the ear. This treatment is unique because it targets the nervous system directly through auricular points, potentially reducing inflammation by altering serum concentrations of inflammatory mediators. Researchers are excited about this approach because it could lead to faster recovery times and fewer side effects compared to conventional treatments, offering a novel pathway for managing the complex symptoms of brain injuries.

What evidence suggests that transcutaneous auricular neurostimulation is effective for traumatic brain injury?

Research suggests that transcutaneous auricular neurostimulation (tAN), which participants in this trial will receive, might alleviate symptoms of traumatic brain injury (TBI). Although direct research on TBI is limited, tAN has shown promise in other areas. For instance, studies have found that tAN can reduce symptoms of opioid withdrawal, and the FDA has approved it for this use, indicating a positive effect on the nervous system. In another study, tAN lowered the amount of blood the heart pumps, which might relate to its potential benefits for brain injury symptoms. These findings offer hope that tAN could help manage issues related to TBI. ^{1 2 3 4 6}

Who Is on the Research Team?

Alex Valadka, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06467708?term=NCT06467708&rank=1

Transcutaneous Auricular Neurostimulation for ICU ... The overarching goal of this pilot study is to assess the feasibility and safety of transcutaneous auricular neurostimulation (tan) in ICU patients with TBi ...

2. sparkbiomedical.com sparkbiomedical.com/healthcare-providers/neurological-health

A Better Way Forward in Opioid Withdrawal Management Sparrow Ascent changes the way opioid withdrawal is managed, offering a non-invasive, FDA-cleared solution that directly targets all withdrawal symptoms.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9385243/

Delivering transcutaneous auricular neurostimulation (tAN) to ... Results demonstrate tAN is a safe and effective non-opioid approach for reducing symptoms of OWS. This study supported an FDA clearance.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05053503

Study Details | NCT05053503 | Delivering Transcutaneous ... The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone ...

5. withpower.com withpower.com/trial/phase-brain-injuries-6-2024-81c90

Auricular Neurostimulation for Traumatic Brain Injury (tAN- ... In a study involving 50 young adults, transcutaneous auricular nerve stimulation (taNS) at 130 µA significantly decreased cardiac output, with distinct gender- ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K230796.pdf

June 20, 2023 Spark Biomedical, Inc. Allison Komiyama, PhD ... The Sparrow Ascent is a transcutaneous nerve field stimulator that is intended to be used in patients experiencing opioid withdrawal in ...