Vestibular Implantation in Older Adults

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05676944
Status
Recruiting
Apply to this trial

Conditions

  • Aminoglycoside Ototoxicity
  • Bilateral Vestibular Deficiency (BVD)
  • Bilateral Vestibular Hypofunction
  • Bilateral Vestibulopathy
  • Gentamicin Ototoxicity
  • Labyrinth Diseases
  • Other Disorders of Vestibular Function, Bilateral
  • Presbyvestibulopathy
  • Sensation Disorders
  • Vestibular Diseases

Eligibility Criteria

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

Interventions

  • Labyrinth Devices MVI™ Multichannel Vestibular Implant System — DEVICE
    Unilateral implantation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System receiver/stimulator including insertion of electrode arrays in the semicircular canal ampullae of the inner ear, followed by motion-modulated prosthetic electrical stimulation.

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 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 fifteen older adults (age 65-90 years at time of enrollment) with ototoxic or non-ototoxic bilateral vestibular hypofunction.

Key Dates

Start date
Apr 11, 2023
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Jan 31, 2028

Study Design

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

Arms

  • Experimental: vestibular implant
    Up to 15 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System

Primary Outcome Measure

PM1.1: Dynamic Gait Index (DGI) during motion-modulated implant stimulation at 6 months post-implantation, relative to pre-operative baseline, aggregated across all implant users. [ Time Frame: Pre-intervention baseline and 6 months post-implantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of MedicineBaltimoreMaryland21287
Claudia Lee
[email protected]
410-502-8209
Charles C Della Santina MDPhD (Lead Surgeon; CEO Labyrinth Devices LLC)
[email protected]
410-502-8047
John P Carey MD (Independent/Nonconflicted IRB Protocol PI) (PRINCIPAL_INVESTIGATOR)
Charles C Della Santina MDPhD (Lead Surgeon; CEO Labyrinth Devices LLC) (SUB_INVESTIGATOR)

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By research site
Johns Hopkins School of Medicine· Baltimore, MD

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