Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

Mayo Clinic

Status: Completed

Conditions: Balance Disorder

Treatments: Device: Vestibular Intervention via Portable Electrical Stimulator (VIPES) system

Study type: Interventional

Funder types: Other

Identifiers

NCT04968197

21-005284

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Stochastic Vestibular Stimulation (SVS) Condition

Experimental group

Description:

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).

Treatment:

Device: Vestibular Intervention via Portable Electrical Stimulator (VIPES) system

Control Condition

No Intervention group

Description:

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