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EUROPEAN DEVELOPMENT OF BIONICS VESTIBULAR IMPLANT FOR BILATERAL VESTIBULAR DYSFUNCTION

Periodic Reporting for period 1 - BionicVEST (EUROPEAN DEVELOPMENT OF BIONICS VESTIBULAR IMPLANT FOR BILATERAL VESTIBULAR DYSFUNCTION)

Reporting period: 2018-09-01 to 2019-08-31

More than 100 million people worldwide suffer from severe vestibular disorders, thus being at high risk of falls and injuries. This seriously handicaps their lives, disabling them of doing routine daily activities, such as driving and even walking. Restoring the function of the vestibular labyrinths was not possible until now, as they are surgically inaccessible due to their complex structure.

The vestibular labyrinths, saccule and utricle, provide sensory input to neural circuits that facilitate accurate perception of spatial orientation and heading, support stable posture, and maintain steady vision. This contributes at 60% to the vestibular function and postural balance. Saccule and utricle function is essential for self-reported dizziness and for postural balance in upright position and gait.

Vertigo of vestibular origin has a global prevalence of approximately 5% and an incidence of 1.5%. It is associated with an increased frequency of medical consultations, sickness and interruption of daily activities. In addition, its chronic, fluctuating and disabling nature has a strong psychological impact that often leads to anxiety and depression, which affects both the patients and their families. In older people, several studies deserves special attention because of its high prevalence, ranging from 38% to 59%, and because of its relationship with the risk of falls, with the consequent emergence of permanent disability, need for institutionalization (10% of cases) and death. Of the 50% accidental death in the elderly, 24% of cases correspond to central vertigo and 15% of cases are of mixed causes.

The economic cost generated exerts a tremendous social impact and constitutes a major public health problem. The cost of falls in the EU for 2020 has been estimated to be 60.000 million euros in Europe. Despite these facts, there is currently no evidence about an effective treatment, except for intensive retraining of balance. The majority of patients do not show long-term improvement in their symptoms or recovery of their vestibular function. The development of a device to replace the vestibular function will revolutionize the treatment of patients with vestibular dysfunction. Target groups to receive vestibular implant include: Bilateral vestibular hypofunction, which affect 1.176.000 people worldwide; unilateral vestibular hypofunction resistant to vestibular rehabilitation, which affects 2.800.000 people worldwide and fluctuating vestibular symptoms like Meniere disease. The number of people susceptible to receive a vestibular implant, 100 million people worldwide (~ 1.5% of the population), is even bigger than for cochlear implants (12-14 millions). As it happened back in the day with the cochlear implant, the creation of a vestibular implant would kick-start an emerging innovative market sector and a new industry around a solid baseline of feasibility, ready for early take-up.

Based on that health unsolved problem, the general objective of the Bionic\VEST is the development of a device to measure the cephalic movements in the three spatial planes and code this information to the vestibular nerve to substitute hair cell sensors in the maculae of the saccule and utricle, or to stimulate the vestibular nerve with a constant pulse train to mitigate disbalance due to malfunction of the otolithic organ. Also, a future step is to integrate a vestibular and a cochlear implant to treat deafness and imbalance with the same system. With Bionic\VEST device, our long-term aim is to first increase quality of life of the patients and second to reduce the cost of falls, in the EU for 2020 has been estimated to be 60.000 million euros, due to vestibular disorder and to increase the quality of life of these patients.
During the first year of Bionic\VEST we have been working on three main aspects:

1) Risk, IPR and business & exploitation plan:
We have been studying the risk that can affect the evolution of the project and we also propose a set of mitigation to continue in case of risk appear.
Regarding IPR the intellectual property (IP) from the ULPGC partner has been transferred to COCH to create new and strong IPs. This will guarantee a future successful and leadership of this technology.
For business & exploitation, we had explored the strength, weakness opportunity and threats to provide this technology to those candidates patients. We had detected a necessity to invest in diagnosis, to aware about this pathology and to define better patient pathways to reduce the misdiagnosis and give an effective treatment.

2) Device development and clinical trial preparation:
During this first year, we have been extensively working on electrode design, integration with cochlear implants, external processor integration, trying to reduce the necessity of external sensors. We had performed some research prototypes external processors at the ULPGC to evaluate the best placement of sensors, in case they are necessary.
On the other hand, we have started in advance to prepare all the clinical documentation to have time to solve future problems (very poor likely).

3) Dissemination:
We have an operative website with public information about the project for the general population. The project has participated in several dissemination activities like Macaronight European researcher night or patent week in Las Palmas de Gran Canaria. The project has also been presented at different scientific events.Then the Twitter account has already 100 followers, with a variety of kinds of users (patients, specialist and technology interest public).
The aim of Bionic\VEST and the experience of this first year is to develop a system to analyze the responses of the vestibular nerve, design, manufacture and test the first vestibular prosthesis to restore the sensation of linear accelerations and finally demonstrate the safety of its use for humans. The electrode placement, the stimulation and the electronic developed in the project obtain the best results with the less cost compare to other competitors on vestibular implants.

The development of vestibular implant also produces a knowledge creation about vestibular physiology. Currently we had present a paper about the importance of the otolith function and the relevance of study the impact in balance. This will lead in a better understanding of the system and its implication can be apply to robotics, aeronautics and in future space flights to reduce the impact of the space sickness in astronauts.

Finally this project aims is the creation of the third bionic sense that will develop in the history of humanity, after Cochlear Implant and Retina Implant. This bring a solution to a pathology that affect to 100 million people worldwide and does not have any alternative.
Flowchart of vestibular implant impact in patients