taVNS for Atrial Fibrillation

Overseen By Harald M Stauss, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Burrell College of Osteopathic Medicine

Must be taking: Anticoagulants

Disqualifiers: Pregnancy, Epilepsy, Vestibulocochlear issues, 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: 3

Duration: 2 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if applying a small electrical current to the ear can help lower the heart rate in patients with persistent irregular heartbeats. The treatment works by slowing down the heart's electrical signals. Patients will use this device daily for a short period to see if it makes a difference.

Will I have to stop taking my current medications?

The trial requires that participants stay on their anti-coagulation medication throughout the study.

What data supports the effectiveness of the treatment taVNS for Atrial Fibrillation?

Research shows that stimulating the vagus nerve through the ear can help reduce atrial fibrillation (irregular heartbeats) and improve heart rate variability, which is a sign of a healthy heart. ^{1 2 3 4 5}

Is transcutaneous auricular vagus nerve stimulation (taVNS) safe for humans?

taVNS is generally considered safe for humans, with mild and temporary side effects like ear pain, headache, and tingling. Studies show no serious adverse effects linked to taVNS, making it a safe option for clinical use. ^{5 6 7 8 9}

How is the treatment taVNS different from other treatments for atrial fibrillation?

taVNS is unique because it is a non-invasive treatment that uses low-intensity electrical currents applied to the ear to stimulate the vagus nerve, potentially reducing atrial fibrillation without the need for surgery or medication. This method is inexpensive, portable, and offers a novel way to modulate the nervous system compared to traditional treatments. ^{1 2 3 6 8}

Research Team

Harald M Stauss, MD, PhD

Principal Investigator

Burrell College of Osteopathic Medicine

Eligibility Criteria

This trial is for adults over 18 with persistent atrial fibrillation who are on anticoagulation therapy. It's not suitable for pregnant individuals, those under 18, or anyone with a history of vestibulocochlear nerve issues like hearing loss or epilepsy.

Inclusion Criteria

I have ongoing irregular heartbeats.

I am taking blood thinners and will continue during the study.

I am 18 years old or older.

Exclusion Criteria

I am not taking blood thinners.

I am under 18 years old.

I have epilepsy or a history of it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants self-administer taVNS or sham-taVNS for 30 minutes daily for two weeks, with continuous ECG monitoring.

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• taVNS

Trial Overview The study tests if non-invasive ear stimulation (taVNS) can reduce heart rate in patients with persistent atrial fibrillation. Participants will self-administer taVNS daily and have their heart activity monitored to see if there's a difference in heart rate reduction.

Participant Groups

Group I: Active Intervention Active Control 1 Intervention

Participants will self-administer active taVNS for 30 min per day for 7 days.

Group II: Sham Intervention Placebo Group 1 Intervention

Participants will self-administer sham-taVNS for 30 min per day for 7 days.

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

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

• Epilepsy
• Depression
• Obesity

Approved in European Union as Transcutaneous Auricular Vagus Nerve Stimulation for:

• Epilepsy
• Depression

Who Is Running the Clinical Trial?

Burrell College of Osteopathic Medicine

Lead Sponsor

Trials

6

Recruited

330+

Findings from Research

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]

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]

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 auricular vagus nerve stimulation (TaVNS) effectively normalized gastric dysrhythmias in healthy individuals during a water-load test, indicating its potential as a treatment for gastric symptoms.

The study found that TaVNS at 40 Hz improved heart rate variability and reduced bloating, suggesting it positively influences both parasympathetic and sympathetic nervous system pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. Du, P., Maharjan, A., Calder, S., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improves depression symptoms, as evidenced by reduced scores on the Hamilton Depression Scale in a review of 12 studies involving 838 participants.

taVNS shows comparable response rates to traditional antidepressants and has fewer side effects, suggesting it could be a safe alternative or complementary treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. Tan, C., Qiao, M., Ma, Y., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and well-tolerated method for treating conditions like drug-resistant epilepsy, but a recent randomized double-blind trial found no significant difference in outcomes between high- and low-stimulation groups.

The most common side effect of taVNS is a tingling sensation or pain at the stimulation site, and while it shows promise, further research is needed to fully understand its efficacy and to potentially gain approval for insurance coverage in Japan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical Application of Transcutaneous Auricular Vagus Nerve Stimulation]. Yamamoto, T.[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]

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]

References

1. 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]

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

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

3. 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]

4. 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]

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

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. [2023]

7. Japan pubmed.ncbi.nlm.nih.gov

[Clinical Application of Transcutaneous Auricular Vagus Nerve Stimulation]. [2022]

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

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

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

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