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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

In this blinded prospective randomized control trial the researchers will investigate the impact of cutaneous vagal nerve stimulation on surgical conditions in patients undergoing functional and ascorbic sinus surgery (FESS). The device is an externally placed vagal nerve stimulator. The device will be applied to participants after consent and induction of anesthesia. The study team will open the randomization envelope and if the participant is assigned to stimulation the device will be turned on. In the case that the participant is assigned to the control arm, the device will be set to sham. The device will remain on for 30 minutes and removed before entering the OR. Device will be reinserted in the recovery room for another 30 minutes.

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 data supports the effectiveness of the treatment Auricular Neuromodulation for Sinus Surgery?

Research shows that auricular vagus nerve stimulation (AVNS) is being explored for various conditions like heart failure and migraines, suggesting its potential to influence bodily functions. Although specific data for sinus surgery is limited, the technique's ability to modulate the nervous system non-invasively indicates promise for broader therapeutic applications. ^{1 2 3 4 5}

Is auricular neuromodulation safe for humans?

Auricular neuromodulation, also known as transcutaneous auricular vagus nerve stimulation (taVNS), is generally considered safe with only mild and temporary side effects like ear pain, headache, and tingling. Studies show no significant risk of severe adverse events, making it a safe option for clinical use. ^{2 5 6 7 8}

How is auricular neuromodulation different from other treatments for sinus surgery?

Auricular neuromodulation is unique because it uses non-invasive electrical stimulation of the ear to activate the vagus nerve, which can influence brain and body functions without the need for surgery or drugs. This method targets specific areas of the ear to modulate nerve activity, offering a novel approach compared to traditional treatments that may involve medication or surgical intervention. ^{1 2 3 4 9}

Research Team

Daniel Katz, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

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

Evaluation of different vagus nerve stimulation anatomical targets in the ear by vagus evoked potential responses. [2021]

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

Toward Diverse or Standardized: A Systematic Review Identifying Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve in Nomenclature. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The anatomical basis for transcutaneous auricular vagus nerve stimulation. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

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

Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. [2022]

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

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

8. England pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Feasibility study on transcutaneous auricular vagus nerve stimulation using millimeter waves. [2022]