Recruiting

Vestibular Implantation

Sponsor:

Johns Hopkins University

Code:

NCT06500975

Conditions

Bilateral Vestibular Hypofunction

Bilateral Vestibular Deficiency

Bilateral Vestibulopathy

Gentamicin Ototoxicity

Aminoglycoside Toxicity

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Labyrinth Devices MVI™ Multichannel Vestibular Implant System

Study Details

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.

Conditions

Bilateral Vestibular Hypofunction

Bilateral Vestibular Deficiency

Bilateral Vestibulopathy

Gentamicin Ototoxicity

Aminoglycoside Toxicity

Study ID

NCT06500975

Start date

Dec 1, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vestibular Implant

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

Interventions

Labyrinth 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)

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 ]
  • PM1.2: Gain (VHITG) of the vestibulo-ocular reflex (VOR), as measured using the video head impulse test (vHIT) [ Time Frame: 4 years post-implantation up to 5 years post-enrollment ]

Central Contacts and Locations

Central contacts

Kelly Lane

410-502-8047vestibularimplant@jhmi.edu

Charles C Della Santina, MDPhD

410-502-8047cds@jhmi.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Lauren N Trainer, BS

410-502-5129vestibularimplant@jhmi.edu

Charles C Della Santina, MDPhD

410-502-8047vestibularimplant@jhmi.edu

Principal Investigator:

John P Carey, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • Vestibular
  • Implant
  • Prosthesis
  • Labyrinth
  • Ototoxicity
  • Gentamicin
  • Oscillopsia
  • Disequilibrium
  • Dizziness
  • Vestibulopathy
  • Inner Ear

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-03-09.