Long Term Outcomes After Vestibular Implantation
Recruiting now · Not applicable
Conditions studied: Bilateral Vestibular Hypofunction, Bilateral Vestibular Deficiency, Bilateral Vestibulopathy, Gentamicin Ototoxicity, Aminoglycoside Toxicity, Vestibular Diseases, Sensation Disorders, Labyrinth Diseases, Other Disorders of Vestibular Function
In brief
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.
Key facts
- Study ID
- NCT06500975
- Run by
- Johns Hopkins University
- People needed
- 32
- Starts
- 2024-12-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-03-09
Who can join
Age: 22 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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