Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

Balance Disorder Clinical Trial

Official title:

Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04968197
• Other study ID #: 21-005284
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 31, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Balance Disorder

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Balance Performance	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.	Through study completion, approximately 1.5 hours

External Links

•   Mayo Clinic Clinical Trials