balance disorder Bilateral vestibulopathy
Conditions
Interventions
To evaluate combined prolonged stimulation of both the vestibular organ and the cochlea, subjects will be implanted with a cochlear-vestibular implant (CVI). This extended CI also incorporates a vesti
and tests conducted during regular CI follow-up visits until 5 years after implantation, including 3 CBCT scans (12 hours extra during standard visits). An overview of 
the trial schedule is given in figure 1 of the research protocol. More detailed overviews can be found in chapter 3. For multiple-day hospital visitations, the patients will have the option to stay in
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Disabling symptoms of bilateral vestibulopathy - Severe sensorineural hearing loss in the ear to be implanted A full list of the inclusion criteria can be found in chapter 4.2 of the research protocol
Exclusion criteria
Exclusion criteria: - Clear signs of structural nerve pathology or indications of improperly functioning vestibular nerves - Orthopedic, ocular, neurologic or other non-vestibular pathologic conditions of sufficient severity to confound vestibular function tests used in the study A full list of the exclusion criteria can be found in chapter 4.3 of the research protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is assessing the efficacy of the CVI in restoring vestibular function. This will be measured by using a set of vestibular tests, of which DVA will be the main outcome parameter. The tests that will be performed observe two vestibular-related reflex pathways: VOR (gaze stabilization) and VSR (postural balance). The VOR tests consist of the DVA test, the functional head impulse test (fHIT), the 3D video head impulse test (3D HIT) and the torsion swing test. All these tests quantify the VOR at different frequencies and at different levels of functionality. The VSR is observed based gait and balance tests, looking at the full body response to vestibular stimulation on a functional level. Besides these tests, also the threshold of the perception of movement will be measured using the perception platform. The functionality of the CI-part of the CVI will be assessed with an aided consonant-nucleus-consonant (CNC) hearing test. During the CI follow-up visits speech in noise (SPIN) tests will be performed as part of the auditory follow-up test battery to allow for evaluation of the CI part of the CVI implant and compare this outcome with CI performance of a regular CI implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| The patients subjective experience with the CVI will be quantified using both questionnaires and a number of semi-structured interviews at different points during the study duration. An overview of the time points at which questionnaires and interviews will be administered can be found in table 1, 2, 3 and 4 of the research protocol. The results of these questionnaires and interviews will allow us to more extensively describe our patient population, quantify the impact that both the CI and the VI functionality have on patient well-being, characterize the perceived benefit the CVI will pose to the patient and allow us to see if the CVI meets the patients expectations. All this data will also be vital for creating a health technology assessment (HTA), which will aid the further development of the concept of vestibular stimulation. | — |
Countries
Netherlands
Contacts
Public ContactR Berg
Maastricht Universitair Medisch Centrum +
Outcome results
None listed