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.
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Safety of vestibular stimulation via the CVI
Timeframe: Through full trial period, up to 5 years postoperatively
The feasibility of vestibular stimulation improving Dynamic Visual Acuity during walking
Timeframe: Through all stimulation periods, within 5 years after implantation
The feasibility of vestibular stimulation improving Dynamic Visual Acuity during passive head movements
Timeframe: Through each 4-day VI stimulation period, within 2 years after implantation
The feasibility of vestibular stimulation restoring the high-frequency vestibulo-ocular reflex
Timeframe: Through each 4-day VI stimulation period, within 2 years after implantation
The feasibility of vestibular stimulation restoring the low-frequency vestibulo-ocular reflex
Timeframe: Through each 4-day VI stimulation period, within 2 years after implantation
The feasibility of vestibular stimulation improving the self-movement perception in dark
Timeframe: Through each 4-day VI stimulation period, within 2 years after implantation
The feasibility of vestibular stimulation improving gait stability and balance based on motion capture data on a treadmill
Timeframe: Through each 4-day VI stimulation period, within 2 years after implantation
The feasibility of vestibular stimulation improving gait stability and balance based on motion capture data overground
Timeframe: Through each home-use phase, within 5 years after implantation
The feasibility of vestibular stimulation improving balance based on clinical evaluation
Timeframe: Through each 4-day VI stimulation period, within 2 years after implantation
Speech perception with CVI in quiet without simultaneous vestibular stimulation
Timeframe: Through the full trial period, until 5 years after implantation
Interaction between vestibular and cochlear stimulation on speech perception in quiet
Timeframe: Through each 4-day VI stimulation period, within 2 years after implantation
Speech perception with CVI in noise without simultaneous vestibular stimulation
Timeframe: Through the full trial period, until 5 years after implantation
Change in otolith function due to CVI implantation
Timeframe: preoperatively and 1 month postoperatively
Vestibular and cochlear electrode location
Timeframe: Through the full trial period, until 5 years after implantation