Auricular Neuromodulation for Sinus Surgery

Overseen By Samuel DeMaria, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Anti-fibrinolytics

Disqualifiers: Coagulation disorders, Pregnancy, Epileptic seizures, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether stimulating a nerve in the ear, known as Auricular Neuromodulation, can improve conditions during sinus surgery. Participants will receive either actual nerve stimulation or a sham version to compare outcomes. Individuals planning elective sinus surgery, without certain medical conditions or devices like pacemakers, might be suitable candidates. The trial focuses on those who can safely undergo the procedure without affecting the results. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used anti-fibrinolytic drugs within 30 days before enrolling.

What prior data suggests that this device is safe for use in sinus surgery?

Research has shown that auricular neuromodulation, also known as ear-based vagal nerve stimulation, is generally safe for people. Studies indicate that this treatment does not cause serious side effects such as low blood pressure or slow heart rates. Participants using this method reported satisfaction. Another study found that this type of nerve stimulation improved quality of life and mood without causing harmful effects. Overall, current evidence suggests this treatment is well-tolerated and safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Auricular neuromodulation is unique because it offers a non-invasive approach to managing sinus conditions by using electrostimulation via the ear. Unlike traditional sinus treatments, which often involve medications like decongestants, antihistamines, or surgery, this technique targets the nervous system to potentially alleviate symptoms. Researchers are excited about this method because it could provide a new way to help patients without the need for drugs or invasive procedures, offering a promising alternative with potentially fewer side effects.

What evidence suggests that auricular neuromodulation is effective for sinus surgery?

Research has shown that stimulating the ear through transcutaneous auricular vagus nerve stimulation (taVNS) can effectively reduce post-surgical pain. In a study on patients who underwent perianal surgery, taVNS eased pain without additional complications. This method has also improved quality of life, mood, and mental function in people with epilepsy. Additionally, taVNS is linked to a slight decrease in heart rate, suggesting calming effects. In this trial, participants will join either an electrostimulation group, where the device will be activated to send electrostimulation, or a sham group, where the device will be set to Sham, providing no electrostimulation. These findings suggest that ear stimulation could aid in managing pain and recovery in surgeries, such as sinus surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Daniel Katz, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for healthy individuals (ASA 1 and 2) scheduled for elective sinus surgery (FESS). It's not open to those with pacemakers, cochlear implants, neurostimulators, clotting disorders, obesity, smokers, pregnant women, recent blood transfusions or anti-fibrinolytic drug use, ear infections or abnormalities.

Inclusion Criteria

ASA 1 and 2

I am scheduled for elective sinus surgery.

Exclusion Criteria

Presence of device such as pacemaker, cochlear prosthesis, neurostimulator

Hypercoagulable state, including morbid obesity and active smoking

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo functional endoscopic sinus surgery with the application of the neuromodulation device for 30 minutes before and after surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-operative outcomes such as nausea, vomiting, and pain in the PACU

3 hours

1 visit (in-person)

Long-term follow-up

Participants are monitored for any long-term effects or complications post-surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Auricular Neuromodulation

Trial Overview The study tests the Sparrow Ascent tAN System's effect on surgical conditions during FESS. Participants are randomly chosen to receive either real vagal nerve stimulation or a sham treatment before and after surgery while under anesthesia.

How Is the Trial Designed?

Group I: Electrostimulation Experimental Treatment 1 Intervention

Device will be turned on to send electrostimulation.

Group II: Sham - no electrostimulation Placebo Group 1 Intervention

Device will be toggled to Sham so no electrostimulation will be given.

Auricular Neuromodulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Cluster headaches
• Migraines
• Epilepsy
• Treatment-resistant depression

Approved in European Union as Auricular Vagus Nerve Stimulation for:

• Epilepsy
• Treatment-resistant depression
• Cluster headaches
• Migraines

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

The study demonstrates that millimeter wave (MMW) stimulation can selectively activate the auricular branch of the vagus nerve (ABVN) without affecting nearby non-vagal nerves, as shown by significant increases in local field potential (LFP) power in the nucleus tractus solitarii (NTS) during targeted stimulation.

In contrast, non-vagal nerve stimulation resulted in decreased LFP power, indicating that MMW can effectively differentiate between vagal and non-vagal responses, paving the way for a new clinical treatment approach for conditions like depression and epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study on transcutaneous auricular vagus nerve stimulation using millimeter waves. Song, HY., Shin, DW., Jung, SM., et al.[2022]

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]

In a study involving 26 subjects, simultaneous stimulation of the cymba and concha (CC) areas of the ear using extra-large electrodes was found to be the most effective for eliciting vagus somatosensory evoked potentials (VSEP), indicating strong neuromodulation effects.

The research demonstrated that the earlobe is not an effective target for taVNS, and using larger electrodes not only increased the amplitude of the response but also made the stimulation more comfortable for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of different vagus nerve stimulation anatomical targets in the ear by vagus evoked potential responses. de Gurtubay, IG., Bermejo, P., Lopez, M., et al.[2021]

Vagus nerve stimulation (VNS) is effective for treating refractory epilepsy and depression, but traditional methods involve surgical implantation, which carries risks such as infection and bradycardia.

New non-invasive VNS systems eliminate the need for surgery, improving safety and tolerability, and allowing patients to administer stimulation on demand, potentially expanding its use in various medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Ben-Menachem, E., Revesz, D., Simon, BJ., et al.[2022]

A systematic review of 261 studies revealed significant confusion in the nomenclature for transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN), with 67 full and 27 abbreviated terms identified, highlighting the need for standardization.

The most commonly used terms were 'transcutaneous vagus nerve stimulation' and 'tVNS', but there was no consistent one-to-one relationship between full and abbreviated names, indicating a lack of uniformity in terminology across different research teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Diverse or Standardized: A Systematic Review Identifying Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve in Nomenclature. Wang, Y., Li, L., Li, S., et al.[2023]

Vagus nerve stimulation (VNS), particularly through non-invasive methods like transcutaneous VNS (tVNS), shows promise for treating various clinical disorders, including heart failure and migraines, by stimulating the auricular branch of the vagus nerve without the need for surgical implantation.

Current research highlights the need for more detailed studies on the neuroanatomy of the auricular branch of the vagus nerve (ABVN) to better understand its therapeutic effects and optimize stimulation parameters, as existing literature lacks consensus on the most effective stimulation sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anatomical basis for transcutaneous auricular vagus nerve stimulation. Butt, MF., Albusoda, A., Farmer, AD., et al.[2022]

Auricular vagal nerve stimulation (AVNS) is a promising neuromodulation technique with potential therapeutic applications, but its mechanisms of action may involve more complex neural networks than previously thought, including connections beyond the auricular branch of the vagus nerve.

The review highlights the importance of understanding the intricate anatomy and neural connections in the auricular region, which could lead to improved interpretations of AVNS research and better future studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concerning Auricular Vagal Nerve Stimulation: Occult Neural Networks. Cakmak, YO.[2020]

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 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/NCT06662422

NCT06662422 | Auricular Neuromodulation for FESS In this blinded prospective randomized control trial the researchers will investigate the impact of cutaneous vagal nerve stimulation on surgical conditions ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11894745/

Impact of transcutaneous auricular vagus nerve stimulation on ... taVNS effectively alleviates postoperative pain in patients undergoing perianal surgery without increasing the risk of complications.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838258

Transcutaneous Auricular Vagus Nerve Stimulation for ... Main Outcomes and Measures The primary outcome was the incidence of moderate to severe postpartum uterine contraction pain on the third ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923000223

Transcutaneous Auricular Vagus Nerve Stimulation (ta- ... The present study showed that ta-VNS is an effective and safe therapy for epilepsy. Furthermore, the benefit in QOL, mood, and cognitive state of ta-VNS needs ...

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2021.664740/full

Auricular Vagus Neuromodulation—A Systematic Review ... There is evidence of a modest decrease in heart rate during higher stimulation dosages, sometimes at above the level of sensory discomfort.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8120162/

Auricular Vagus Neuromodulation—A Systematic Review on ... Studies on epilepsy reached primary endpoints similar to previous RCTs testing implantable vagus nerve stimulation therapy. Preliminary evidence shows that aVNS ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/07853890.2025.2476045

Impact of transcutaneous auricular vagus nerve stimulation ... No adverse reactions like hypotension or bradycardia were observed in either group. Patient satisfaction was higher in the taVNS group (p < 0.05). Conclusion.

8. elifesciences.org elifesciences.org/reviewed-preprints/100088

The effect of transcutaneous auricular vagus nerve ... Our study found that taVNS treatment did not induce adverse cardiovascular effects, such as bradycardia or QT prolongation, supporting its development as a ...