Health TrialsbyHealthPanel

A Study Of Auricular Transcutaneous Vagus Nerve Stimulation In Chronic Dizziness

ConditionsChronic DizzinessPersistent Postural Perceptual Dizziness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The purpose of this study is to measure the change in dizziness, as measured by change in Dizziness Handicap Inventory (DHI) score, following a 4-week treatment period with auricular transcutaneous vagus nerve stimulation (aTVNS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75, Persistent Postural-Perceptual Dizziness (PPPD) diagnosis per International Classification of Vestibular Disorders (ICVD).

Persistent dizziness ≥3 months and at least 1 dizziness exacerbation/day during 2-week run-in.

On stable medications/therapy for ≥4 weeks prior to baseline (if any).

Disqualifiers

Uncompensated peripheral/central vestibular deficit, sensory-afferent or cerebellar ataxia.

Cardiac disease (coronary disease, unstable arrhythmia), recurrent syncope (>1 in past 12 months).

Neck surgery, vagotomy, or any condition interfering with vagal stimulation.

Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sham Device

    Other intervention

    The sham control uses the same stimulation devices as the active group, but with modified electrodes that do not emit electrical current. Instead, they produce a mechanical vibration or clicking sensation that mimics the feeling of stimulation without delivering current to the skin.

  • Auricular transcutaneous vagus nerve stimulation

    Other intervention

    The Parasym AVNT is a noninvasive, transcutaneous auricular vagus nerve stimulator (tVNS) designed to deliver low-level electrical stimulation to the auricular branch of the vagus nerve through the skin of the outer ear. The stimulator produces mild, pulsed electrical currents typically ranging from 0.1 to 5.0 milliampere (mA) at frequencies between 20-30 Hz and pulse widths of approximately 200-300 μs. The stimulation intensity is adjusted individually to produce a light tingling sensation without discomfort or visible muscle contraction.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Auricular transcutaneous vagus nerve stimulationExperimental treatment 1 intervention
Group B: Sound sham electrodesSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in Dizziness Handicap Inventory (DHI) score

The Dizziness Handicap Inventory (DHI) is a 25-item questionnaire assesses physical, emotional, and functional aspects of dizziness. Each of the 25 questions has three answers: "Always" (4 points), "Sometimes" (2 points), or "No" (0 points). Scores are summed for a total from 0 (no disability) to 100 (maximum disability).

Time frame
Baseline, 4 weeks

Secondary outcomes

1

Change in Anxiety (HADS-A)

The Hospital Anxiety and Depression (HAD) is a self-reported 14 item questionnaire asking participants to reflect on their mood in the past week. . Each item is rated on a 4-point scale, for a total score ranging from 0-21 for each subscale. A higher score indicates higher distress. Clinically meaningful change is defined as a ≥2-3-point reduction.

Time frame
Baseline, 4 weeks and 8 weeks
2

Change in Postural Sway

Postural sway will be measured using Computerized Dynamic Posturography. A ≥10-15% reduction will be considered a meaningful improvement.

Time frame
Baseline, 4 weeks and 8 weeks
3

Weekly averages of dizzy-day frequency

Frequency of dizzy days will be tracked via patient treatment diary

Time frame
Through end of study, approximately 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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