- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04968197
Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
January 30, 2023 updated by: Gaurav N. Pradhan, Mayo Clinic
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Recruiting
- Mayo Clinic in Arizona
-
Contact:
- Jody Devine
- Phone Number: 480-301-6767
- Email: devine.jody@mayo.edu
-
Contact:
- Armando Rivera
- Phone Number: 480-301-4251
- Email: Rivera.Armando2@mayo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must be able to consent to participate themselves.
- Participants must be 21 to 55 years of age.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stochastic Vestibular Stimulation (SVS) Condition
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).
|
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.
|
No Intervention: Control Condition
Subjects will perform standard clinical testing for balance and gait without SVS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in balance performance
Time Frame: Through study completion, approximately 1.5 hours
|
Change in balance performance during balance testing by measuring sway score across tested levels of GVR amplitude and control condition.
|
Through study completion, approximately 1.5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gaurav N Pradhan, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Anticipated)
December 30, 2023
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
July 7, 2021
First Submitted That Met QC Criteria
July 7, 2021
First Posted (Actual)
July 20, 2021
Study Record Updates
Last Update Posted (Actual)
February 1, 2023
Last Update Submitted That Met QC Criteria
January 30, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 21-005284
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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