Safety Issues
Conditions
Keywords
Neuromodulation, Safety, Vestibular
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.
Interventions
DEVICEVestal DM
Battery powered non-invasive neurostimulation device (1.5mA)
Sponsors
R D Gardi Medical College, Ujjain
Neurovalens Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Vestal DM user (more than 6 months)
Exclusion criteria
* Vestal DM device user (less than 6 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of hearing function as reported by formal audiometry testing | Baseline | Formal audiometry testing to be conducted using the AMTAS Flex Device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of device related adverse events | Baseline | — |
| 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 |
| 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). |
Countries
United Kingdom
Outcome results
None listed