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OpenTrials
Completed

NCT Number: NCT04783883

Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up 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.

Completed

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Key information

Conditions

Safety Issues

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurovalens Ltd., 7 James St. South

Belfast, BT2 8DN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Vestal DM user (more than 6 months)

Exclusion criteria

  • Vestal DM device user (less than 6 months)

Treatment and study plan

Vestal DM

Device

Battery powered non-invasive neurostimulation device (1.5mA)

Primary outcomes

  1. Assessment of hearing function as reported by formal audiometry testing

    Time frame: Baseline

    Formal audiometry testing to be conducted using the AMTAS Flex Device

Secondary outcomes

  1. Frequency of device related adverse events

    Time frame: Baseline

  2. 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

  3. 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).

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Neurovalens Ltd.

Industry

Collaborators

  • R D Gardi Medical College, Ujjain

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2021
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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