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

Neurovalens Ltd.25 enrolled

Overview

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

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

Conditions

Safety Issues

Interventions

Vestal DMDEVICE

Battery powered non-invasive neurostimulation device (1.5mA)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Vestal DM user (more than 6 months) Exclusion Criteria: * Vestal DM device user (less than 6 months)

Locations (1)

Neurovalens Ltd., 7 James St. South

Belfast, United Kingdom

Outcomes

Primary Outcomes

Assessment of hearing function as reported by formal audiometry testing

Formal audiometry testing to be conducted using the AMTAS Flex Device

Time frame: Baseline

Secondary Outcomes

Frequency of device related adverse events

Time frame: Baseline

Inspection of the skin behind the ears (mastoid area)

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

Time frame: Baseline

Otoscope examination of the inside of both ear canals and tympanic membranes

Photographs to be taken of both ear canals and both tympanic membranes using the Awelor Wireless Smart Otoscope (Model Number: T1).

Time frame: Baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.