NCT04968197|CompletedResultsFDA Device
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Sponsor study identifier
interventional
23
1 country
1
Study Start
September 1, 2022
Actual (reported)Primary Completion
March 16, 2023
Actual (reported)Study Completion
December 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2021
Actual (reported)July 20, 2021
Actual (reported)September 1, 2022
Actual (reported)March 16, 2023
Actual (reported)December 31, 2023
Actual (reported)June 13, 2024
Actual (reported)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
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).
Subjects will perform standard clinical testing for balance and gait without SVS
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Gaurav N Pradhan
Mayo Clinic
23 participants (actual enrollment reported by the registry).
First Submitted
July 7, 2021
First Posted
July 20, 2021
Study Start
September 1, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 16, 2023
Actual (reported)Study Completion
December 31, 2023
Actual (reported)Last Updated
June 13, 2024
Results First Posted
June 13, 2024
Record last verified: 2024-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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