Long Term Outcomes After Vestibular Implantation

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06500975
Status
Recruiting
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Conditions

  • Aminoglycoside Toxicity
  • Bilateral Vestibular Deficiency
  • Bilateral Vestibular Hypofunction
  • Bilateral Vestibulopathy
  • Gentamicin Ototoxicity
  • Labyrinth Diseases
  • Other Disorders of Vestibular Function
  • Sensation Disorders
  • Vestibular Diseases

Eligibility Criteria

Sex
ALL
Age
22 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Labyrinth Devices MVI™ Multichannel Vestibular Implant System — DEVICE
    Continuously motion-modulated stimulation delivered by a vestibular implant already implanted under a prior study protocol (Labyrinth Devices MVI™ Multichannel Vestibular Implant System)

Study Details

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 Dates

Start date
Dec 1, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vestibular Implant
    Up to 32 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System (MVI)

Primary Outcome Measure

PM1.1: Dynamic Gait Index (DGI)18 during motion-modulated implant stimulation at 4 years post-implantation, relative to pre-operative baseline, aggregated across all implant users. [ Time Frame: 4 years post-implantation up to 5 years post-enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of MedicineBaltimoreMaryland21287
Lauren N Trainer, BS
[email protected]
410-502-5129
Charles C Della Santina, MDPhD
[email protected]
410-502-8047
John P Carey, MD (PRINCIPAL_INVESTIGATOR)
Charles C Della Santina, MDPhD (SUB_INVESTIGATOR)

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Johns Hopkins School of Medicine· Baltimore, MD

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