N/A
N=23
Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
Balance Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04968197 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in Balance Performance — 0.52; 0.42; 0.51; 0.48 degrees per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vestibular Intervention via Portable Electrical Stimulator (VIPES) system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Balance Performance |
0.52; 0.42; 0.51; 0.48; 0.63; 0.55 | — |
Summary
The purpose of this study is to develop a vestibular interventional approach using stochastic vestibular stimulation (SVS) through a small, lightweight device, and a comfortable electrode set on the back of the head that stimulates the vestibular system and produces immediate improvements in balance, gait, and overall vestibular function for patients will balance disorder.
Eligibility Criteria
Inclusion Criteria
- Participants must be able to consent to participate themselves.
- Must be able to attend in-person sessions at the Mayo Aerospace Medicine and - Vestibular Research Laboratory in Scottsdale, AZ.
- No racial/ethnic groups will be excluded.
- All participants must be fluent speakers of English.
Exclusion Criteria
- Presence of peripheral vestibulopathy (cleared by Dix-Hallpike, vHIT as part of clinical evaluation).
- Women who are pregnant.
- Inability to complete testing (e.g., severe symptom burden, inability to stand unassisted).
Data sourced from ClinicalTrials.gov (NCT04968197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.