Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

Mayo Clinic1 site in 1 country23 target enrollmentSeptember 1, 2022

ConditionsBalance Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Balance Disorder
Sponsor: Mayo Clinic
Enrollment: 23
Locations: 1
Primary Endpoint: Change in Balance Performance
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 1, 2022

End Date

December 31, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Gaurav N. Pradhan

Principal Investigator

Mayo Clinic

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).

Outcomes

Primary Outcomes

Change in Balance Performance

Time Frame: Through study completion, approximately 1.5 hours

Change in balance performance during balance testing by measuring the center of gravity sway (degrees per second) across tested levels of GVR amplitude and control condition.