NCT06500975 Long Term Outcomes After Vestibular Implantation
| NCT ID | NCT06500975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Bilateral Vestibular Hypofunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2024-12-01 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
John P Carey, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT06500975 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 90 Years, studying Bilateral Vestibular Hypofunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06500975 currently recruiting?
Yes, NCT06500975 is actively recruiting participants. Contact the research team at vestibularimplant@jhmi.edu for enrollment information.
Where is the NCT06500975 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06500975 clinical trial?
NCT06500975 is sponsored by Johns Hopkins University. The principal investigator is John P Carey, MD at Johns Hopkins School of Medicine. The trial plans to enroll 32 participants.