Vagus Auricular Stimulation for Tinnitus

(VAST Trial)

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with bothersome tinnitus, a ringing or buzzing noise in the ears without an external source. Participants will be randomly assigned to use either an active auricular stimulation device (Vagus Auricular Stimulation) or a sham device. Both groups will also participate in mindfulness-based stress reduction sessions to help reduce the impact of tinnitus and improve well-being. This trial suits English-speaking adults who have experienced moderate to severe tinnitus and are available for the entire study period. As an unphased trial, it offers participants the opportunity to contribute to innovative research that may lead to new treatment options for tinnitus.

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.

What prior data suggests that this auricular stimulation device is safe for tinnitus treatment?

Research has shown that vagus nerve stimulation in the ear, a treatment under study for tinnitus, is generally safe. Studies have found that this stimulation typically causes only mild and short-lived side effects, such as slight tingling or discomfort at the device's placement site.

One study highlighted the safety of this method when combined with music therapy for chronic tinnitus. No serious side effects were reported, and participants generally tolerated the treatment well. While research on this tinnitus treatment continues, these findings suggest a promising safety profile based on current evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about vagus auricular stimulation for tinnitus because it offers a novel approach compared to traditional treatments like sound therapy, cognitive behavioral therapy (CBT), and medication. Unlike these options, which mainly focus on masking the noise or altering the brain's perception of it, this new method directly targets the nervous system by stimulating the vagus nerve through the ear. This could potentially reset the brain's auditory pathways and reduce the perception of tinnitus. Additionally, when combined with Mindfulness-Based Stress Reduction (MBSR), it may enhance the overall effectiveness by promoting acceptance and reducing stress, which is often linked to tinnitus severity.

What evidence suggests that vagus auricular stimulation is effective for tinnitus?

This trial will compare two approaches for managing tinnitus symptoms. One group will receive vibrational stimulation of the vagus nerve in the ear combined with Mindfulness-Based Stress Reduction (MBSR). Studies have shown that stimulating the vagus nerve can help reduce tinnitus symptoms. Specifically, research indicates that combining this nerve stimulation with sound therapy improved symptoms in 40% of participants, with effects lasting at least two months. Another group will receive a sham device alongside MBSR. While the treatment doesn't completely eliminate tinnitus, it can make the symptoms more manageable for many people. Overall, evidence suggests this technique could be promising for those dealing with bothersome tinnitus. ^{3 6 7 8 9}

Who Is on the Research Team?

Jay F Piccirillo, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11110564/

Efficacy and safety of transcutaneous auricular vagus nerve ...

This protocol aims to synthesise and update the evidence to clarify whether ta-VNS is effective and safe for alleviating tinnitus.

2.

frontiersin.org

frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1405310/full

Current status of transcutaneous auricular vagus nerve ...

2.1 taVNS reduces tinnitus questionnaire scores, but cannot improve tinnitus complaints: an open pilot study. A study published in Brain ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06821893

NCT06821893 | Vagus Auricular Stimulation for Tinnitus

This pilot study is a randomized, double-blinded controlled trial of adult participants with chronic, moderate to severe bothersome subjective tinnitus.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0079612320301485

Vagus nerve stimulation for tinnitus: A review and perspective

Vagus nerve stimulation is a promising new tool for the treatment of chronic tinnitus. Current protocols produce a clinically significant but moderate ...

5.

nature.com

nature.com/articles/s41598-017-12178-w

Vagus Nerve Stimulation Paired with Tones for ... - Nature

After 4 weeks of daily VNS-tone pairing, tinnitus symptoms improved in 40% of the participants and this improvement lasted for at least 2 months ...

6.

nature.com

nature.com/articles/s41598-022-25864-1

Safety of transcutaneous auricular vagus nerve stimulation ...

Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11254635/

Current status of transcutaneous auricular vagus nerve ...

The use of taVNS for the treatment of tinnitus cannot be recommended in its current form. 3.The data suggest taVNS to be considered safe in ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1935861X22002078

The efficacy and safety of transcutaneous auricular vagus ...

Both auriculotherapy and vagus nerve stimulation are effective on improving cognitive functions. However, there is no double blinded randomized clinical trial ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4704553/

Feasibility and Safety of Transcutaneous Vagus Nerve ...

This study has demonstrated the feasibility and safety of tVNS paired with notched music therapy in patients with chronic tinnitus.