Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

Not Applicable

Completed

• Conditions: Balance Disorder
• Interventions: Device: Vestibular Intervention via Portable Electrical Stimulator (VIPES) system

• Registration Number: NCT04968197
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-20
• Study Start: 2022-09-01
• Primary Completion: 2023-03-16
• Study Completion: 2023-12-31
• Results First Submitted: 2024-04-19
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Results First Posted: 2024-06-13
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Stochastic Vestibular Stimulation (SVS) Condition	Vestibular Intervention via Portable Electrical Stimulator (VIPES) system	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).

Primary Outcome Measures

Name	Time	Method
Change in Balance Performance	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.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States