A Study Of Vibrotactile Belt For Persistent Postural-Perceptual Dizziness (PPPD)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 26-003880
About this study
The purpose of this study is to investigate the usability, safety, feasibility, and efficacy of the BalanceBelt vibrotactile device for patients with moderate-to-severe persistent postural-perceptual dizziness (PPPD) over 12-weeks of treatment and 6 months of follow-up.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Participants must be 18 years of age or older.
Participants must have a primary neurotologic diagnosis of PPPD according to the International Classification of Vestibular Disorders. They also must have a total score on the DHI greater than 30 at study entry.
Participants must not be receiving active treatment for PPPD, although maintenance of a stable established treatment program will be permitted as long as residual symptoms are causing at least moderate handicap (DHI total score >30).
Participants must be able to ambulate independently.
Participants must be willing and able to provide informed consent and complete all study procedures
Exclusion Criteria:
Patients with any untreated or insufficiently treated illnesses other than PPPD that cause vestibular or balance symptoms will be excluded, although those with stable co-existing illnesses will be eligible.
Patients currently using medications or other substances (e.g., cannabinoids) to suppress vestibular function will be excluded unless they can discontinue these medications or substances before study entry.
Patients planning to start or change the dose of any serotonin reuptake inhibitors for any reason will be excluded because these medications can treat PPPD, although those taking maintenance doses of these medications for any illness will be permitted.
Patients who are planning to start or change doses of medications that can suppress vestibular function or alter postural control will be excluded, even if those medication adjustments are intended to treat other illnesses, although potential participants taking stable maintenance doses of these medications for other illnesses will be permitted.
Patients with an active alcohol or other substance use disorder will be excluded because alcohol and most substances of abuse can affect vestibular and balance function.
Individuals with active illnesses causing debilitating levels of physical or psychiatric symptoms other than dizziness (e.g., chronic pain syndromes, uncontrolled major depression) will be ineligible to limit confounds from chronic comorbidity.
Patients who must use gait or mobility aids will be excluded.
Patients unable to wear the BalanceBelt safely and properly due to reasons such as pregnancy or an incompatible waist circumference (i.e., smaller than the smallest or larger than largest available sizes of the belt) will be excluded.
Individuals who have been treated with a vibrotactile device previously will not be eligible.
Individuals using any external or implanted neuromodulation devices will not be eligible.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 07/14/2026. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jeffrey Staab, M.D. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available