NCT04783883

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2021

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

March 3, 2021

Last Update Submit

January 15, 2024

Conditions

Safety Issues

Keywords

NeuromodulationSafetyVestibular

Outcome Measures

Primary Outcomes (1)

  • Assessment of hearing function as reported by formal audiometry testing

    Formal audiometry testing to be conducted using the AMTAS Flex Device

    Baseline

Secondary Outcomes (3)

  • Frequency of device related adverse events

    Baseline

  • Inspection of the skin behind the ears (mastoid area)

    Baseline

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

    Baseline

Interventions

Vestal DMDEVICE

Battery powered non-invasive neurostimulation device (1.5mA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Vestal DM device users from any country.

You may qualify if:

  • Vestal DM user (more than 6 months)

You may not qualify if:

  • Vestal DM device user (less than 6 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurovalens Ltd., 7 James St. South

Belfast, BT2 8DN, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 5, 2021

Study Start

March 4, 2021

Primary Completion

July 5, 2021

Study Completion

July 23, 2021

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations

GB(1)