VertiGO! - In balance with the artificial balance organ

VertiGO! further explores the vestibular implant (VI) as a treatment option for patients with severe vestibular function loss. This consortium, in which universities, patients and a medical device manufacturer participate, is set out to evaluate chronic stimulation with the VI in a clinical setting.

The vestibular system, a tiny sensory organ, is essential for balance and image stabilisation. It drives the eyes to keep the image of the environment stable. Severe function loss of both vestibular organs is referred to as bilateral vestibulopathy (BV). Patients with BV experience imbalance, disorientation, vertigo and discomfort during all types of movements, leading to severe impairments in day-to-day activities. It has been estimated that more than 500.000 people in Europe and 3 million people worldwide are affected. Up till now no effective treatment is available for these patients.

The VertiGO! trial will include eight new patients with bilateral vestibular function loss. They will be implanted with the latest version of the vestibular implant (VI). The primary objectives of this trial are: 1) evaluate the safety and efficacy of daily VI stimulation within a clinical environment, 2) compare two types of stimulation algorithms and 3) develop a rehabilitation program. Both stimulation algorithms will be applied in a random order for one week with a period of one week in between. During these weeks of testing, patients will be admitted by Maastricht UMC+. Relevant outcome measures will be investigated.

The vestibular implant (VI) allows for clinically restoring balance and gaze functionality for the first time. No clinically available VI is on the market today. The VertiGO! trial will be the first chronic daily stimulation trial in a controlled setting in humans. The resulting insights will take patient perspectives into account and will form the basis for product development and future market release of the VI.