Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Balance Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Stochastic Vestibular Stimulation (SVS) Condition

Subjects will perform standard clinical testing for balance and gait while wearing the Vestibular Intervention via Portable Electrical Stimulator (VIPES) system. The SVS device will be active throughout the testing at the respective current levels (i.e., 0.2mA to 1 mA at 0.2 mA increments).

Group Type EXPERIMENTAL

Vestibular Intervention via Portable Electrical Stimulator (VIPES) system

Intervention Type DEVICE

A small, lightweight device able to deliver stochastic vestibular stimulation (SVS) using a comfortable electrode set on the back of the head as well as other proven modes of galvanic vestibular stimulation (GVS) related vestibular correction when required to mitigate motion sickness or provide auxiliary vestibular cueing.

Control Condition

Subjects will perform standard clinical testing for balance and gait without SVS

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vestibular Intervention via Portable Electrical Stimulator (VIPES) system

A small, lightweight device able to deliver stochastic vestibular stimulation (SVS) using a comfortable electrode set on the back of the head as well as other proven modes of galvanic vestibular stimulation (GVS) related vestibular correction when required to mitigate motion sickness or provide auxiliary vestibular cueing.

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No