Vagus Auricular Stimulation for Tinnitus

(VAST Trial)

Overseen By Jay F Piccirillo, MD, CPI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Age >70, Pregnancy, Ear pathology, others

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

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This pilot study is a randomized, double-blinded controlled trial of adult participants with chronic, moderate to severe bothersome subjective tinnitus. Participants will be randomly assigned to either an active auricular stimulation device group or a sham-control group.Both groups will also undergo virtual Mindfulness-Based Stress Reduction(MBSR) over 8 weeks to promote tinnitus bother reduction, and general well-being. Outcome measures will be assessed at baseline, end of intervention, and at 1-month post-intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently on active treatment for tinnitus, you would not be eligible to participate.

Is vagus auricular stimulation safe for humans?

Vagus auricular stimulation, specifically transcutaneous auricular vagus nerve stimulation (taVNS), is generally considered safe for humans, with mild and temporary side effects like ear pain, headache, and tingling. Studies show no significant risk of severe adverse events compared to controls. ^{1 2 3 4 5}

How is Vagus Auricular Stimulation treatment different from other tinnitus treatments?

Vagus Auricular Stimulation is unique because it uses non-invasive electrical stimulation of the vagus nerve through the ear, which can help reduce tinnitus symptoms by influencing brain pathways without the need for surgery or drugs. This method is considered patient-friendly and low-cost, offering a novel approach compared to traditional treatments that may not directly target the vagus nerve. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Vagus Auricular Stimulation for tinnitus?

Research shows that stimulating the vagus nerve, including its auricular branch, can help reduce tinnitus symptoms. Studies have found that this type of nerve stimulation is a promising and safe therapy for people with tinnitus, offering a non-invasive and low-cost option. ^{6 7 8 11 12}

Research Team

Jay F Piccirillo, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults with chronic, moderate to severe tinnitus that's bothersome. Participants must be willing to undergo an 8-week virtual Mindfulness-Based Stress Reduction program and can't have conditions that would interfere with the study or its treatments.

Inclusion Criteria

Ability to read, write, speak, and understand English

Available for the entire period of the study including one month follow-up after completion of 8-week intervention period

Access to internet-connected device(s) such as phone, tablet, or laptop with a camera

Exclusion Criteria

I am over 70 years old.

Pregnant or planning to become pregnant during the study period

Previous participation in an auricular stimulation trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 weeks of auricular stimulation and Mindfulness-Based Stress Reduction (MBSR) sessions

8 weeks

Weekly virtual MBSR sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• Vagus Auricular Stimulation

Trial Overview The study tests vibrational stimulation on the ear (active treatment) versus a sham (placebo) control, both combined with MBSR therapy. It aims to see if this can reduce the annoyance of tinnitus and improve well-being, measured before, after treatment, and one month later.

Participant Groups

Group I: Vibrational stimulation + MBSR Experimental Treatment 1 Intervention

Each participant will wear the Auricular stimulation device during the 30 minutes mindfulness exercise portion of the 2-hour MBSR group sessions. Additionally, they will wear the devices during the 20-minute at-home MBSR activities for the remaining six days of the week, totaling 120 minutes. The total expected duration of device usage per week will be 2.5 hours or 150 minutes. Mindfulness Based Stress Reduction: This is a standardized and structured training session that was originally developed by Jon Kabat-Zinn. Its primary objective is to assist participants in accepting their current condition and eliminating negative associations with it. All study participants will receive MBSR

Group II: Sham + MBSR Placebo Group 1 Intervention

Each participant will wear the Sham device device during the 30 minutes mindfulness exercise portion of the 2-hour MBSR group sessions. Additionally, they will wear the devices during the 20-minute at-home MBSR activities for the remaining six days of the week, totaling 120 minutes. The total expected duration of device usage per week will be 2.5 hours or 150 minutes. Mindfulness Based Stress Reduction: This is a standardized and structured training session that was originally developed by Jon Kabat-Zinn. Its primary objective is to assist participants in accepting their current condition and eliminating negative associations with it. All study participants will receive MBSR

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Findings from Research

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. England pubmed.ncbi.nlm.nih.gov

Non-invasive vagus nerve stimulation reduces sympathetic preponderance in patients with tinnitus. [2017]

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

Pulsed Radiofrequency of the Vagal Nerve for Tinnitus -A Case-Study. [2022]

3. Turkey pubmed.ncbi.nlm.nih.gov

Characteristics of Stimulus Intensity in Transcutaneous Vagus Nerve Stimulation for Chronic Tinnitus. [2020]

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

Pulsed Radiofrequency of the Auricular Branch of the Vagal Nerve in Tinnitus Patients. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of transcutaneous vagus nerve stimulation for the treatment of tinnitus: an interventional prospective controlled study. [2023]

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

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

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

Feasibility and Safety of Transcutaneous Vagus Nerve Stimulation Paired with Notched Music Therapy for the Treatment of Chronic Tinnitus. [2020]

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

Tinnitus treatment by vagus nerve stimulation: A systematic review. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Stress and Tinnitus; Transcutaneous Auricular Vagal Nerve Stimulation Attenuates Tinnitus-Triggered Stress Reaction. [2022]

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

Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Direct and Transcutaneous Vagus Nerve Stimulation for Treatment of Tinnitus: A Scoping Review. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical stimulation at auricular acupoints innervated by auricular branch of vagus nerve pairing tone for tinnitus: study protocol for a randomized controlled clinical trial. [2022]