Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

NCT04968197 | Completed Results FDA Device

• 1 other identifier: 21-005284
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Balance Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Stochastic Vestibular Stimulation (SVS) Condition

EXPERIMENTAL

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).

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

Control Condition

NO INTERVENTION

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

Interventions

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.

Stochastic Vestibular Stimulation (SVS) Condition

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Gaurav N. Pradhan, Ph.D.
• Organization: Mayo Clinic

Pradhan.Gaurav@mayo.edu

(480) 301-5351

Study Officials

• Gaurav N Pradhan

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 20, 2021
• Study Start: September 1, 2022
• Primary Completion: March 16, 2023
• Study Completion: December 31, 2023
• Last Updated: June 13, 2024
• Results First Posted: June 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)