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Completed

NCT Number: NCT04968197

Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

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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Key information

Conditions

Balance Disorder

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vestibular Intervention via Portable Electrical Stimulator (VIPES) system

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2021
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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