60 Participants NeededMy employer runs this trial

Vagus Nerve Stimulation for Dizziness

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Overseen ByColton Clayton, Au.D., Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether stimulating the vagus nerve, a key nerve connecting the brain to the body, can reduce dizziness. It targets individuals who have experienced ongoing dizziness for at least three months with daily flare-ups. Participants will use either an active device for auricular transcutaneous vagus nerve stimulation or a sham (inactive) device during daily sessions to determine if the treatment is effective. This trial may suit individuals diagnosed with Persistent Postural-Perceptual Dizziness (PPPD) who maintain stable medication and therapy routines. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new treatment options.

Do I have to stop taking my current medications for the trial?

The trial requires that you have been on stable medications or therapy for at least 4 weeks before starting. It doesn't specify if you need to stop taking them during the trial.

What prior data suggests that this device is safe for treating dizziness?

Research has shown that auricular transcutaneous vagus nerve stimulation (aTVNS) is generally safe. Studies have found that while minor side effects like skin irritation can occur, serious problems are rare and not directly linked to the treatment. One review reported 30 serious issues, but none were confirmed to be caused by aTVNS itself. Most people tolerate the treatment well, making it a promising option for treating dizziness and other conditions.12345

Why are researchers excited about this trial?

Researchers are excited about auricular transcutaneous vagus nerve stimulation for dizziness because it offers a non-invasive approach to treatment, unlike standard medications that often have systemic side effects. This method involves stimulating the vagus nerve through the skin of the ear, which could potentially regulate balance and reduce dizziness symptoms more directly and safely. Additionally, the sham comparator group allows researchers to clearly assess the treatment's effectiveness, which could lead to new, more targeted therapies for people suffering from dizziness.

What evidence suggests that auricular transcutaneous vagus nerve stimulation is effective for dizziness?

Research has shown that stimulating the vagus nerve through the ear (aTVNS) can help reduce dizziness and improve balance. In this trial, participants in the vagus nerve stimulation group will receive active auricular transcutaneous vagus nerve stimulation (aTVNS) for 8 weeks. One study found that adding aTVNS to regular treatment helped with dizziness, balance, tiredness, and anxiety. Another study showed that aTVNS improved the quality of life for people with ongoing dizziness. These findings suggest that aTVNS could be a promising option for easing dizziness symptoms.46789

Who Is on the Research Team?

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Colton Clayton, Au.D., Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who have had ongoing dizziness for at least 3 months, with daily flare-ups, and are diagnosed with Persistent Postural-Perceptual Dizziness (PPPD). Participants should be on stable treatment if taking any medications.

Inclusion Criteria

I have had ongoing dizziness for at least 3 months with daily flare-ups.
I am 18 to 75 years old and have been diagnosed with PPPD.
I have been on the same medications or therapy for at least 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive auricular transcutaneous vagus nerve stimulation or sham treatment for 4 weeks

4 weeks
Daily sessions, 1 hour each

Extended Treatment

Participants in the active treatment group continue with auricular transcutaneous vagus nerve stimulation for an additional 4 weeks

4 weeks
Daily sessions, 1 hour each

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Auricular Transcutaneous Vagus Nerve Stimulation

Trial Overview

The study compares a device that stimulates the vagus nerve through the ear (aTVNS) to a sham (inactive) device over four weeks to see if it helps reduce chronic dizziness symptoms.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Auricular transcutaneous vagus nerve stimulationExperimental Treatment1 Intervention
Group II: Sound sham electrodesPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Investigation of the Effectiveness of Transcutaneous Auricular ...

In conclusion, taVNS treatment in addition to vestibular rehabilitation improved dizziness, balance, fatigue, kinesiophobia, anxiety, and ...

Effects of adding transcutaneous vagus nerve stimulation ...

Furthermore, nVNS has shown clinical benefits in improving balance and quality of life in patients with persistent postural-perceptual dizziness ...

Therapeutic Use of Transcutaneous Vagal Nerve ...

Available data show that tVNS may benefit patients with dizziness and imbalance based on subjective metrics including quality of life and reduction in dizziness ...

Transcutaneous auricular vagus nerve stimulation in ...

taVNS was demonstrated to be safe, with no serious adverse events reported in healthy individuals or in patients with stroke or PD. In terms of ...

Efficacy and safety of transcutaneous auricular vagus nerve ...

The efficacy of ta-VNS was 61.54% in patients with DRE. Patients with high baseline seizure frequency or identifiable etiologies tended to ...

Safety of transcutaneous auricular vagus nerve stimulation ...

Overall, 30 serious adverse events were reported (22 participants from 7 studies), but none of them were confirmed to be caused by ...

A pooled analysis of the side effects of non-invasive ...

Some effects, such as the influence of interval stimulation on neck pain, dizziness, and unpleasant feelings, may hold potential for optimizing ...

Safety and tolerability of Transcutaneous Vagus Nerve ...

tVNS has been safe and well tolerated by research participants to date. · The most common side effect of tVNS was skin irritation (in 18.2%). · 35 (2.6%) tVNS ...

Investigation of the Effectiveness of Transcutaneous ...

In conclusion, taVNS treatment in addition to vestibular rehabilitation improved dizziness, balance, fatigue, kinesiophobia, anxiety, and ...