Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Assessment of Long-term Usage

January 15, 2024 updated by: Neurovalens Ltd.

Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Safety Assessment of Long-Term Usage

A follow-up assessment study of the long-term safety of vestibular electrical stimulation as delivered by the Vestal DM Device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A retrospective, open-label, follow-up study assessing the long-term safety and efficacy of vestibular electrical stimulation as delivered by the Vestal DM Device.

Study Type

Observational

Enrollment (Actual)

25

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

  • United Kingdom
      • Belfast, United Kingdom, BT2 8DN
        • Neurovalens Ltd., 7 James St. South

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Vestal DM device users from any country.

Description

Inclusion Criteria:

  • Vestal DM user (more than 6 months)

Exclusion Criteria:

  • Vestal DM device user (less than 6 months)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of hearing function as reported by formal audiometry testing
Time Frame: Baseline
Formal audiometry testing to be conducted using the AMTAS Flex Device
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of device related adverse events
Time Frame: Baseline
Baseline
Inspection of the skin behind the ears (mastoid area)
Time Frame: Baseline
Photographic inspection of the skin behind the ears to confirm no skin irritation has been caused at the mastoid area where the electrode pads are placed
Baseline
Otoscope examination of the inside of both ear canals and tympanic membranes
Time Frame: Baseline
Photographs to be taken of both ear canals and both tympanic membranes using the Awelor Wireless Smart Otoscope (Model Number: T1).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurovalens Ltd.

Collaborators

R D Gardi Medical College, Ujjain

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)

March 4, 2021

Primary Completion (Actual)

July 5, 2021

Study Completion (Actual)

July 23, 2021

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RWDMES01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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