Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Assessment of Long-term Usage
Completed
- Conditions
- Safety Issues
- Registration Number
- NCT04783883
- Lead Sponsor
- Neurovalens Ltd.
- Brief Summary
A follow-up assessment study of the long-term safety of vestibular electrical stimulation as delivered by the Vestal DM Device.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Vestal DM user (more than 6 months)
Exclusion Criteria
- Vestal DM device user (less than 6 months)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of hearing function as reported by formal audiometry testing Baseline Formal audiometry testing to be conducted using the AMTAS Flex Device
- Secondary Outcome Measures
Name Time Method Frequency of device related adverse events Baseline Otoscope examination of the inside of both ear canals and tympanic membranes Baseline Photographs to be taken of both ear canals and both tympanic membranes using the Awelor Wireless Smart Otoscope (Model Number: T1).
Inspection of the skin behind the ears (mastoid area) 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
Trial Locations
- Locations (1)
Neurovalens Ltd., 7 James St. South
🇬🇧Belfast, United Kingdom