Chronic Dizziness, Persistent Postural Perceptual Dizziness
Conditions
Keywords
Vagus Nerve Stimulation
Brief summary
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).
Interventions
OTHERSham Device
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.
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dizziness Handicap Inventory (DHI) score | Baseline, 4 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety (HADS-A) | Baseline, 4 weeks and 8 weeks | 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. |
| Change in Postural Sway | Baseline, 4 weeks and 8 weeks | Postural sway will be measured using Computerized Dynamic Posturography. A ≥10-15% reduction will be considered a meaningful improvement. |
| Weekly averages of dizzy-day frequency | Through end of study, approximately 8 weeks | Frequency of dizzy days will be tracked via patient treatment diary |
Countries
United States
Contacts
CONTACTColton Clayton, Au.D., Ph.D.
PRINCIPAL_INVESTIGATORColton Clayton, Au.D., Ph.D.
Mayo Clinic
Outcome results
None listed