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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783883
• Other study ID #: RWDMES01
• Status: Completed
• Start date: March 4, 2021
• Est. completion date: July 23, 2021

Study information

• Verified date: January 2024
• Source: Neurovalens Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 23, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Vestal DM user (more than 6 months)

Exclusion Criteria:

• Vestal DM device user (less than 6 months)

Related Conditions & MeSH terms

• Safety Issues

Intervention

Device:
• Vestal DM
Battery powered non-invasive neurostimulation device (1.5mA)

Locations

Country	Name	City	State
United Kingdom	Neurovalens Ltd., 7 James St. South	Belfast

Sponsors (2)

Lead Sponsor	Collaborator
Neurovalens Ltd.	R D Gardi Medical College, Ujjain

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of hearing function as reported by formal audiometry testing	Formal audiometry testing to be conducted using the AMTAS Flex Device	Baseline
Secondary	Frequency of device related adverse events		Baseline
Secondary	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	Baseline
Secondary	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).	Baseline