Long Term Outcomes After Vestibular Implantation
Johns Hopkins University
Summary
Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research focused on ototoxic cases has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, yielding a total of fifteen adults (age 22-90 years at time of enrollment) divided as equally as possible between ototoxic and non-ototoxic cases.
Description
There is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to loss of semicircular canal function despite vestibular rehabilitation exercises. The experience of 15 adults with bilateral vestibular hypofunction who underwent unilateral surgical placement of a vestibular implant and have received continuously motion-modulated electrical stimulation of the vestibular nerve for \>6 months revealed vestibular implantation (VI) and motion-modulated stimulation can partially restore vestibular sensation and re…
Eligibility
- Age range
- 22–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Adults older than 22 years old who * have previously been enrolled in Johns Hopkins University Institutional Review Board protocol NA\_00051349, IRB00335294 or IRB00346924 and * have previously been implanted with a vestibular implant under FDA IDE G150198
Interventions
- DeviceLabyrinth Devices MVI™ Multichannel Vestibular Implant System
Continuously motion-modulated stimulation delivered by a vestibular implant already implanted under a prior study protocol (Labyrinth Devices MVI™ Multichannel Vestibular Implant System)
Location
- Johns Hopkins School of MedicineBaltimore, Maryland