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Multichannel Vestibular Implant Early Feasibility Study

This study is currently recruiting participants.
Verified September 2017 by Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02725463
First Posted: April 1, 2016
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Labyrinth Devices, LLC
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition Intervention
Other Disorders of Vestibular Function, Bilateral Bilateral Vestibular Deficiency (BVD) Gentamicin Ototoxicity Labyrinth Diseases Vestibular Diseases Sensation Disorders Device: Labyrinth Devices MVI™ Multichannel Vestibular Implant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: April 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vestibular implant
From up to 60 enrolled and screened subjects, up to 5 subjects will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System
Device: Labyrinth Devices MVI™ Multichannel Vestibular Implant

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults age 22.0-90 with bilateral vestibular deficiency not responsive to vestibular rehabilitation as determined by pre-inclusion history, vestibular testing and clinical examination
  • Hearing status: (1) Hearing in the candidate ear for implantation is equivalent to or worse than that in the contralateral ear; and (2) hearing in the contralateral ear is good enough to allow functional communication in case hearing in the implanted ear is lost after implantation. Specifically, the contralateral ear must satisfy all of the following criteria:

    1. 0.5/1/2/4 kilohertz (kHz) pure-tone-average threshold (PTA) hearing better than (i.e., less than) 70 dB hearing loss (HL); and
    2. ear-specific sentence recognition score using the recorded AzBio Sentence Test presented at 60 dB sound pressure level A (SPL-A) in quiet must be >60% when tested under either the unaided condition or, if 0.5/1/2/4 kHz PTA>50 dB, the best-aided condition; and
    3. ear-specific word recognition score using the recorded Consonant-Nucleus-Consonant (CNC) Word Recognition Test presented at 60 decibels hearing level (dB HL) in quiet must be >60% when tested under either the unaided condition or, if 0.5/1/2/4 kHz PTA>50 dB, the best-aided condition
  • Caloric responses consistent with severe or profound bilateral loss of labyrinthine function (total caloric response to warm and cool caloric stimuli <10°/sec in each ear; lack of a reversal of response on ice-water caloric stimulation when subject reorients from supine to prone)
  • Prior MRI imaging of the brain, internal auditory canals and cerebellopontine (CP) angle showing a patent labyrinth, present vestibular nerve, patent cochlea, present cochlear nerve, and absence of internal auditory canal/cerebellopontine angle tumors or other central causes of vestibulo-ocular reflex dysfunction or sensorineural hearing loss
  • Prior CT imaging of the temporal bones showing a facial nerve canal with normal caliber and course, middle ear without evidence of chronic otitis media or tympani membrane perforation or cholesteatoma, a mastoid cavity with adequate aeration for surgical access to each semicircular canal, skull thickness ≥3 mm at the planned well site, and scalp soft tissue thickness ≤7 mm. This criterion may be satisfied without additional imaging if an existing head CT or MRI already demonstrates those findings
  • Vaccinations as recommended per Johns Hopkins Listening Center protocols to reduce the risk of meningitis in subjects undergoing cochlear implantation, as described at this site: http://www.hopkinsmedicine.org/otolaryngology/specialty_areas/listencenter/vaccine.html
  • Motivated to travel to the study center, to undergo testing and examinations required for the investigational study, and to participate actively in a vestibular rehabilitation exercise regimen
  • The participant must agree not to swim or to use or operate vehicles, heavy machinery, powered tools or other devices that could pose a threat to the participant, to others, or to property throughout the duration of participation in the study and until at least 1 month after final deactivation of the MVI Implant

Exclusion Criteria:

  • Inability to understand the procedures and the potential risks involved as determined by study staff
  • Inability to participate in study procedures due to blindness, ≤ ±10° neck range of motion, cervical spine instability, ear canal stenosis or malformation sufficient to prevent caloric testing
  • Diagnosis of acoustic neuroma/vestibular schwannoma, chronic middle ear disease, cholesteatoma, or central nervous system causes of vestibulo-ocular reflex dysfunction, including chronic and continuing use of medications, drugs or alcohol at doses sufficiently great to interfere with vestibular compensation
  • Vestibular dysfunction known to be caused by reasons other than labyrinthine injury due to ototoxicity, ischemia, trauma, infection, Meniere's disease, or genetic defects known to act on hair cells
  • Lack of labyrinth patency or vestibular nerve as determined by MRI of the brain with attention to the internal acoustic meatus
  • Any contraindication to the planned surgery, anesthesia, device activation and deactivation, or participation in study assessments, as determined by the surgeon, anesthesiologist, or designee, including known intolerance of any materials used in any component of the investigational devices that will come in contact with the subject
  • History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention within 6 months prior to screening
  • Subjects with estimated glomerular filtration rate (GFR) < 30 ml/min at screening
  • Subjects with heart failure New York Heart Association (NYHA) class III or IV
  • Subjects with Child-Pugh class C cirrhosis
  • A psychiatric disease or substance abuse history likely to interfere with protocol compliance
  • Contraindications to scleral coil eye movement testing, including monocular blindness and a history of fainting vagal reactions to prior eye manipulations would exclude subjects from eye coil testing
  • Inability to tolerate baseline testing protocols
  • Recent corneal injury
  • A history of cervical spine disease preventing head rotation
  • A history of fainting or vagal reactions prior to eye manipulations that would preclude 3D eye movement coil testing
  • Pregnancy, positive urine or serum pregnancy test at any time during study participation,
  • Ability to become pregnant combined with failure or refusal to consistently use a highly effective method of contraception from at least 1 month prior to implantation to not before 1 month after both device deactivation and conclusion of study participation.
  • Women who are nursing/lactating
  • Any medical condition, judged by the investigator team, that is likely to interfere with a study candidate's participation in the study or likely to cause serious adverse events during the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725463


Contacts
Contact: Desi Schoo, MD 410-955-7876 vestibularimplant@jhmi.edu
Contact: Charles C Della Santina, PhD MD 410-502-7909 ext 2 cds@jhmi.edu

Locations
United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Desi Schoo, MD    410-955-7876    vestibularimplant@jhmi.edu   
Contact: Charles C Della Santina, PhD MD    410-502-7909 ext 2    vestibularimplant@jhmi.edu   
Sub-Investigator: Charles C Della Santina, PhD MD         
Principal Investigator: John P Carey, MD         
Sponsors and Collaborators
Johns Hopkins University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Labyrinth Devices, LLC
Investigators
Principal Investigator: John P Carey, MD Johns Hopkins School of Medicine
  More Information

Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02725463     History of Changes
Other Study ID Numbers: NA_00051349
R01DC013536 ( U.S. NIH Grant/Contract )
JHU80640 ( Other Identifier: Labyrinth Devices, LLC )
First Submitted: January 12, 2016
First Posted: April 1, 2016
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication of de-identified data via peer-reviewed journals

Keywords provided by Johns Hopkins University:
vestibular
implant
prosthesis
labyrinth
ototoxicity
gentamicin
oscillopsia
disequilibrium
dizziness
vestibulopathy
inner ear

Additional relevant MeSH terms:
Disease
Vestibular Diseases
Sensation Disorders
Labyrinth Diseases
Labyrinthitis
Bilateral Vestibulopathy
Pathologic Processes
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Otitis