Vagus Nerve Stimulation for Healthy Subjects

Overseen By Gabriel Gonzalez, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Buprenorphine

Disqualifiers: Chronic pain, Unstable medical condition, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 hours

30 Participants Needed

Trial Summary

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 are currently taking Buprenorphine or have stopped taking it within the last month.

What data supports the effectiveness of the treatment Biphasic and Monophasic transcutaneous auricular vagus nerve stimulation?

Research shows that stimulating the auricular branch of the vagus nerve can improve heart rate variability, which is a measure of heart health, and may have antiarrhythmic effects, potentially reducing the risk of irregular heartbeats. ^{1 2 3 4 5}

How does transcutaneous auricular vagus nerve stimulation differ from other treatments?

Transcutaneous auricular vagus nerve stimulation (tVNS) is unique because it is a non-invasive method that stimulates the vagus nerve through the skin of the ear, avoiding the need for surgical implantation. This approach is relatively new compared to other vagus nerve stimulation techniques and is being explored for its potential benefits in various conditions, such as heart issues and migraines, by modulating nerve activity without invasive procedures. ^{1 2 4 6 7}

What is the purpose of this trial?

The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.

Research Team

Marlon Wong, PT, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for healthy English-speaking adults aged 18-80 who can consent and complete interviews in English. It's designed to see how comfortable and effective different types of gentle electrical ear stimulation are.

Inclusion Criteria

I can speak English and consent to interviews in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive transcutaneous auricular vagus nerve stimulation (taVNS) with different waveforms to assess comfort and tolerability

6 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Biphasic transcutaneous auricular vagus nerve stimulation
• Monophasic transcutaneous auricular vagus nerve stimulation

Trial Overview The study tests two kinds of transcutaneous auricular vagus nerve stimulation (taVNS): monophasic and biphasic. Participants will experience these mild electrical waves through the ear to determine comfort levels and effectiveness.

Participant Groups

Group I: Biphasic followed by monophasic taVNS group Experimental Treatment 2 Interventions

Participants in the group "Biphasic followed by monophasic taVNS" will be in this group for up to 6 hours.

Group II: Monophasic followed by biphasic taVNS group Active Control 2 Interventions

Participants in the group "monophasic followed by biphasic" will be in this group for up to 6 hours.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

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]

Transcutaneous vagus nerve stimulation (tVNS) is gaining interest for its non-invasive application in research and clinical settings, but there is a need for better reporting practices to ensure safety and comparability across studies.

The review proposes a set of minimal reporting items for future tVNS studies, including technical details, participant criteria, and outcome measures, to enhance the reliability and effectiveness of this therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International Consensus Based Review and Recommendations for Minimum Reporting Standards in Research on Transcutaneous Vagus Nerve Stimulation (Version 2020). Farmer, AD., Strzelczyk, A., Finisguerra, A., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) showed significant effects on heart rate variability in healthy individuals, with 86% of studies reporting improvements in standard deviation of NN intervals and other heart rate metrics.

Baroreflex sensitivity results were less consistent, with only one out of six studies showing significant changes, indicating that the effectiveness of taVNS may vary based on individual autonomic function and the need for standardized study designs in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the effects of transcutaneous auricular vagus nerve stimulation on baroreflex sensitivity and heart rate variability in healthy subjects. Soltani, D., Azizi, B., Sima, 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]

Acupuncture at the auricular branch of the vagus nerve (ABVN) significantly reduced heart rate by approximately 4%-6% and increased heart rate variability (HRV) as measured by SDNN by about 19% in a study of 24 healthy male volunteers.

These results suggest that ABVN acupuncture may activate the parasympathetic nervous system, although the overall effects on other HRV parameters were modest and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture at the auricular branch of the vagus nerve enhances heart rate variability in humans: An exploratory study. Boehmer, AA., Georgopoulos, S., Nagel, J., et al.[2022]

Noninvasive transcutaneous stimulation of the auricular branch of the vagus nerve (AB-VNS) significantly reduces spontaneous ventricular arrhythmias in beagle dogs after myocardial infarction, indicating its potential as an antiarrhythmic treatment.

AB-VNS enhances ventricular electrical stability and reduces ventricular interstitial fibrosis, although it does not improve overall cardiac function or reverse structural changes in the heart after 4 weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation reduces ventricular arrhythmias and increases ventricular electrical stability. Nasi-Er, BG., Wenhui, Z., HuaXin, S., et al.[2019]

Tactile stimulation at the auricular branch of the vagus nerve using air pressure significantly enhances parasympathetic activity, as evidenced by changes in heart rate and heart rate variability metrics in 22 healthy participants.

The study found significant differences in heart rate and heart rate variability between baseline and stimulation periods, suggesting that this method could have potential clinical applications, although further research is needed to optimize stimulation parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory Investigation of the Effects of Tactile Stimulation Using Air Pressure at the Auricular Vagus Nerve on Heart Rate Variability. Lee, HJ., Wi, S., Park, S., et al.[2023]

References

1. 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]

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

International Consensus Based Review and Recommendations for Minimum Reporting Standards in Research on Transcutaneous Vagus Nerve Stimulation (Version 2020). [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

A systematic review of the effects of transcutaneous auricular vagus nerve stimulation on baroreflex sensitivity and heart rate variability in healthy subjects. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Acupuncture at the auricular branch of the vagus nerve enhances heart rate variability in humans: An exploratory study. [2022]

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

Vagus nerve stimulation reduces ventricular arrhythmias and increases ventricular electrical stability. [2019]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Exploratory Investigation of the Effects of Tactile Stimulation Using Air Pressure at the Auricular Vagus Nerve on Heart Rate Variability. [2023]