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ACTIVE NOT RECRUITING
NCT04918745
NA

VertiGO! - Get up and GO! With the Vestibular Implant

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

Summary

In the VertiGO! trial 13 participants with bilateral vestibulopathy (BV) and severe sensory neural hearing loss in the ear to be implanted will receive a combined cochlear (CI) and vestibular implant (VI), capable of stimulating both the cochlear and vestibular nerves (CVI). The participants will firstly make use of this combined stimulation during 3 weeks of prolonged use under direct supervision in a hospital environment. Following this, participants will make use of combined stimulation in a real-life environment (e.g., outside of the hospital setting) for 15 months under indirect supervision. This trial will serve as a proof-of-concept for restoring vestibular function in patients with BV, an as-of-yet untreatable disorder causing severe impairment and discomfort. The aims of this trial are to investigate efficacy and safety of prolonged vestibular stimulation, to identify the influence of different stimulation algorithms, to assess the feasibility of the combined VI/CI device, to develop a VI rehabilitation program and to further build on the fundamental knowledge of vestibular organ stimulation while also taking into account the patient perspective.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2021-07-01

Completion Date

2029-06-30

Last Updated

2026-01-16

Healthy Volunteers

No

Interventions

DEVICE

Cochlear Vestibular Implant (CVI)

The Cochlear Vestibular Implant (CVI) is a modified cochlear implant (CI) which also incorporates a vestibular component (VI) in order to restore both hearing and vestibular function. During the in-hospital part, three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are: * A - Baseline stimulation, no modulation stimulation * B - Baseline stimulation, modulated stimulation * C - Reduced baseline stimulation, modulated stimulation During the home-use part, a preference phase will be included to assess the effects of a "control". Participants will receive two research processors, each with a different vestibular stimulation mode. These modes will be randomized over a 4-week period, each appearing twice (2 treatments appearing twice each x 4 weeks = 6 arms). These stimulation modes are: * 1 - individualized vestibular stimulation * 2 - control vestibular stimulation

Locations (1)

Maastricht UMC+

Maastricht, Limburg, Netherlands