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

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.

Conditions

• Bilateral Vestibular Loss

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

Sponsors & Collaborators

• University Hospital, Geneva

  collaborator OTHER

• MED-EL Elektromedizinische Geräte GesmbH

  collaborator INDUSTRY

• Health Holland

  collaborator OTHER

• Heinsius-Houbolt Fund

  collaborator UNKNOWN

• Radboud University Medical Center

  collaborator OTHER

• Stichting de Weijerhorst

  collaborator UNKNOWN

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Raymond van de Berg, MD, PhD · Maastricht UMC

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2027-06-30

Completion

2029-06-30

Countries

• Netherlands

Study Locations