Clinical Trial: Multichannel Vestibular Implant Early Feasibility Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: First-in-Human Early Feasibility Study of Safety, Tolerability and Efficacy for a Multichannel Vestibular Implant in Individuals With Bilateral Severe-to-Profound Loss of Vestibular Sensation

Brief Summary: Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to loss of vestibular hair cell function. Preclinical studies have demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular prosthesis can partially restore vestibular reflexes that maintain steady posture and vision. This pilot clinical feasibility study of a multichannel vestibular implant system will evaluate this approach in up to ten human subjects with bilateral vestibular deficiency due to gentamicin ototoxicity or other causes of inner ear dysfunction.

Detailed Summary: The system used in this study is the (MVI)™ Multichannel Vestibular Implant System produced by Labyrinth Devices, LLC. It is similar to commercially available cochlear implants in that it includes an implanted stimulator powered and controlled by an external unit, which communicate with the implant across the skin via an inductive link. Unlike a cochlear implant, the implanted stimulator's electrode array is designed for implantation near the ends of the vestibular nerve. The implanted stimulator also includes additional magnets to help facilitate retention of the external unit on the scalp over the implant. The external unit includes a head-worn unit (for sensing head motion and delivering power and signals to the implanted stimulator) and a power and control unit containing a battery and microprocessor. Participants in this trial who meet candidacy criteria and who choose to proceed with implantation surgery, device activation and device deactivation will be asked to participate in a series of post-operative monitoring visits over a 1 year period.
Sponsor: Johns Hopkins University

Current Primary Outcome:

  • Identified adverse events to assess the safety of the Labyrinth Devices Multichannel Vestibular Implant (MVI). [ Time Frame: through study completion, an average of 1 year, that is: in visits 0-13 ]
    Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events v4.3 (CTCAE v4.3)
  • Change in 0.5/1/2/4 kilohertz (kHz) pure tone threshold average to assess the effects of MVI on cochlear function [ Time Frame: through study completion, an average of 1 year, that is: in visits 0, 3-10, and 13 ]
    decibels (dB) during 4 intervals (pre-operative, post-implantation/pre-activation, post-activation, and post-deactivation)
  • Change in three-dimensional (3D) angular vestibulo-ocular reflex (VOR) gain [dimensionless] during ~150 deg/sec passive head impulse with modulated prosthetic input to assess the preliminary efficacy of the MVI [ Time Frame: through study completion, an average of 1 year, that is: in visits 0, 3-10 ]
    VOR gain (eye velocity / -head velocity)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Consonant-vowel nucleus-consonant (CNC) speech recognition scores to assess the effects of MVI™ implantation and use on cochlear function [ Time Frame: through study completion, an average of 1 year, that is: in visits 0, 3-10, and 13 ]
    CNC speech recognition scores during 4 intervals (pre-operative, post-implantation/pre-activation, post-activation, and post-deactivation)
  • Arizona Biomedical (AzBio) speech recognition scores to assess the effects of MVI™ implantation and use on cochlear function [ Time Frame: through study completion, an average of 1 year, that is: in visits 0, 3-10, and 13 ]
    AzBio scores during 4 intervals (pre-operative, post-implantation/pre-activation, post-activation, and post-deactivation)
  • Vestibulo-ocular reflex (VOR) three-dimensional (3D) alignment to assess the preliminary efficacy of the MVI [ Time Frame: In a period of up to 24 weeks, in visits 0 and 3 through 10 ]
    Measured in degrees.
  • Ocular Vestibular Evoked Myogenic Potentials (oVEMP) to assess the effects of MVI™ implantation and use on utricular function [ Time Frame: In a period of up to 24 weeks, in visits 0 and 3 through 10 ]
    oVEMP peak-to-peak amplitude in microvolts
  • Cervical Vestibular Evoked Myogenic Potentials (cVEMP) to assess the effects of MVI implantation and use on saccular function [ Time Frame: In a period of up to 24 weeks, in visits 0 and 3 through 10 ]
    cVEMP peak-to-peak amplitude in microvolts
  • Changes in scores on 36-Item Short Form Health Survey (SF-36) to assess the effects of MVI implantation and use on activities of daily living and quality of life. [ Time Frame: In a period of up to 24 weeks, in visits 0, 6, 8, and 10 ]
    SF-36 score
  • Changes in scores on Tinnitus Reaction Questionnaire (TRQ) to assess the effects of MVI implantation and use on activities of daily living and quality of life. [ Time Frame: In a period of up to 24 weeks, in visits 0, 6, 8, and 10 ]
    TRQ score
  • Changes in scores on Dizziness Handicap Inventory (DHI) to assess the effects of MVI implantation and use on activities of daily living and quality of life. [ Time Frame: In a period of up to 24 weeks, in visits 0, 6, 8, and 10 ]
    DHI score
  • Changes in scores on the Health Utilities Index 3 (HUI3) to assess the effects of MVI implantation and use on activities of daily living and quality of life. [ Time Frame: In a period of up to 24 weeks, in visits 0, 6, 8, and 10 ]
    HUI3 scores
  • Changes in scores on the Vestibular Activities of Daily Living (VADL) to assess the effects of MVI implantation and use on activities of daily living and quality of life. [ Time Frame: In a period of up to 24 weeks, in visits 0, 6, 8, and 10 ]
    VADL score
  • Changes in scores on the bilateral vestibular deficiency BVD-case definition subset of questions to assess the effects of MVI implantation and use on activities of daily living and quality of life. [ Time Frame: In a period of up to 24 weeks, in visits 0, 6, 8, and 10 ]
    BVD-case definition subset of questions from the National Health Interview Survey 2008 Balance Questions (NHIS) score
  • Head thrust dynamic visual acuity (htDVA) to assess the feasibility and preliminary efficacy of the MVI™ [ Time Frame: In a period of up to 24 weeks, in visits 0 and 3 through 10 ]
    htDVA test score in log10 of the Minimum Angle Resolvable (LogMAR) units, as the difference between raw htDVA LogMAR and static visual acuity LogMAR
  • Bruininks-Oseretsky test of motor proficiency- balance subtest 2 (BOT2) to assess the feasibility and preliminary efficacy of the MVI™ [ Time Frame: In a period of up to 24 weeks, in visits 0 and 3 through 10 ]
    BOT2 score
  • Dynamic Gait Index (DGI) to assess the feasibility and preliminary efficacy of the MVI™ [ Time Frame: In a period of up to 24 weeks, in visits 0 and 3 through 10 ]
    DGI score
  • Gait speed to assess the feasibility and preliminary efficacy of the MVI™ [ Time Frame: In a period of up to 24 weeks, in visits 0 and 3 through 10 ]
    walking speed in meters per second


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: January 12, 2016
Date Started: April 2016
Date Completion: March 2018
Last Updated: April 1, 2016
Last Verified: April 2016