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Multichannel Vestibular Implant Early Feasibility Study

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.
 
ClinicalTrials.gov Identifier: NCT02725463
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : May 22, 2020
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Labyrinth Devices, LLC
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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
Study Start Date : April 2016
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vestibular implant
Up to 15 subjects will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System
Device: Labyrinth Devices MVI™ Multichannel Vestibular Implant



Primary Outcome Measures :
  1. Identified adverse events to assess the safety and tolerability of the Labyrinth Devices Multichannel Vestibular Implant (MVI™) [ Time Frame: through study completion, an average of 1 year, that is: in visits 0 through 10 ]
    Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events v4.3 (CTCAE v4.3)

  2. Assess the feasibility and preliminary efficacy of the MVI, as determined by changes in 3-dimensional vestibulo-ocular reflex (3D VOR) gain and alignment compared to pre-intervention values and published data from subjects with normal vestibular function [ Time Frame: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10 ]
    VOR gain (eye velocity / -head velocity)

  3. Assess the effects of MVI implantation and use on cochlear function, as indicated by changes in pure tone audiometry [ Time Frame: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10 ]
    Pure tone audiometry (decibels [dB])

  4. Assess the effects of MVI implantation and use on cochlear function, as indicated by changes in Consonant-vowel nucleus-consonant (CNC) speech recognition scores [ Time Frame: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10 ]
    CNC speech recognition score (0-100% correct), higher scores means better outcome

  5. Assess the effects of MVI implantation and use on cochlear function, as indicated by changes in Arizona Biomedical (AzBio) sentence recognition scores [ Time Frame: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10 ]
    AzBio sentence recognition score (0-100% correct), higher scores means better outcome


Secondary Outcome Measures :
  1. Change in 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

  2. Change in 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

  3. Change in 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

  4. 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 (0 to 100), higher scores means better outcome

  5. Changes in scores on Tinnitus Handicap Inventory (THI) 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 ]
    THI score (0-100), higher scores means worse outcome

  6. 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 (0-100), higher scores means worse outcome

  7. 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 (0-1), higher scores means better outcome

  8. 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 (1-10), higher scores means worse outcome

  9. Changes in scores on the Autophony Index (AI) 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 ]
    AI score (0-104), higher scores means worse outcome

  10. 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 (no scale)

  11. Change in Dynamic visual acuity (DVA) 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 ]
    DVA test score in log10 of the Minimum Angle Resolvable (LogMAR) units, as the difference between raw DVA LogMAR and static visual acuity LogMAR

  12. Change in Bruininks-Oseretsky test of motor proficiency- balance subtest 2 (BOT2) to assess the effect of MVI implantation and use on motor proficiency and postural stability [ Time Frame: In a period of up to 24 weeks, in visits 0, and 3 through 10 ]
    BOT2 score (0-36), higher scores means better outcome

  13. Change in Dynamic Gait Index (DGI) to assess the effect of MVI implantation and use on gait and stability [ Time Frame: In a period of up to 24 weeks, in visits 0, and 3 through 10 ]
    DGI score (0-24), higher scores means better outcome

  14. Change in gait characteristics using the GaitRite™ system to assess the effect of MVI implantation and use on gait [ Time Frame: In a period of up to 24 weeks, in visits 0, and 3 through 10 ]
    Gait speed analysis in meters per second, and stride variability



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.


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

Inclusion Criteria:

  1. 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
  2. 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 kHz pure-tone-average threshold (PTA) hearing better than (i.e., less than) 70 dB HL; and
    2. ear-specific sentence recognition score using the recorded AzBio Sentence Test presented at 60 dB 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 dBHL 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
  3. Caloric responses consistent with severe or profound bilateral loss of labyrinthine function, as indicated by one or more of the following: (a) summed speed of caloric responses to warm and cool supine caloric stimuli totaling <10°/sec per ear for each of both ears; (b) summed speed of ice water caloric responses during supine and prone head orientation tests totaling <10°/sec per ear for each of both ears; or (c) speed of ice water caloric responses during supine head orientation tests <5°/sec per ear for each of both ears, with a lack of nystagmus reversal on quickly flipping from supine to prone
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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:

  1. Inability to understand the procedures and the potential risks involved as determined by study staff
  2. 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
  3. 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
  4. 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
  5. Lack of labyrinth patency or vestibular nerve as determined by MRI of the brain with attention to the internal acoustic meatus
  6. 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
  7. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to screening
  8. Orthopedic, neurologic or other nonvestibular pathologic conditions of sufficient severity to confound posture and gait testing or other tests used in the study to assay vestibular function.
  9. Subjects with estimated glomerular filtration rate (GFR) < 30 ml/min (MDRD formula) at screening
  10. Subjects with heart failure NYHA class III or IV
  11. Subjects with Child-Pugh class C cirrhosis
  12. A psychiatric disease or substance abuse history likely to interfere with protocol compliance
  13. 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
  14. Inability to tolerate baseline testing protocols
  15. Recent corneal injury
  16. A history of cervical spine disease preventing head rotation
  17. A history of fainting or vagal reactions prior to eye manipulations that would preclude 3D eye movement coil testing
  18. Pregnancy, positive urine or serum pregnancy test at any time during study participation,
  19. 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. Highly effective contraception methods include:

    Total abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception for purposes of defining exclusion criteria for this study

    Female sterilization (surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before entering the study. A woman who has undergone oophorectomy without hysterectomy may participate in the study only after her reproductive status has been confirmed by subsequent hormone level assessment

    For female subjects of child-bearing potential, study participation is not excluded if the study candidate's male partner is the sole partner of the study candidate and has been vasectomized.

    Combination of any two of the following:

    Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example, hormone vaginal ring or transdermal hormone contraception

    Placement of an intrauterine device (IUD) or intrauterine system (IUS)

    Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository In case of use of oral contraception, women should have been stabile on the same pill for a minimum of 3 months before taking study treatment.

  20. Women who are nursing/lactating
  21. 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.

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
Layout table for location contacts
Contact: Kelly Lane (Study Coordinator) 410-955-7876 vestibularimplant@jhmi.edu
Contact: Charles C Della Santina MDPhD (Lead Surgeon; CEO Labyrinth Devices LLC) 410-502-8047 cds@jhmi.edu

Locations
Layout table for location information
United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kelly Lane    410-955-7876    vestibularimplant@jhmi.edu   
Contact: Charles C Della Santina, MDPhD    410-502-8047    vestibularimplant@jhmi.edu   
Sub-Investigator: Charles C Della Santina MDPhD (Lead Surgeon; CEO Labyrinth Devices LLC)         
Principal Investigator: John P Carey MD (Independent/Nonconflicted IRB Protocol PI)         
Sponsors and Collaborators
Johns Hopkins University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Labyrinth Devices, LLC
Investigators
Layout table for investigator information
Principal Investigator: John P Carey MD (Independent/Nonconflicted IRB Protocol PI) Johns Hopkins School of Medicine
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02725463    
Other Study ID Numbers: NA_00051349
R01DC013536 ( U.S. NIH Grant/Contract )
JHU80640 ( Other Identifier: Labyrinth Devices, LLC )
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication of de-identified data via peer-reviewed journals
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Beginning 6 months after publication and ending 36 months after publication.
Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal and signed data access agreement. Proposals should be directed to vestibularimplant@jhmi.edu.
Keywords provided by Johns Hopkins University:
vestibular
implant
prosthesis
labyrinth
ototoxicity
gentamicin
oscillopsia
disequilibrium
dizziness
vestibulopathy
inner ear
Additional relevant MeSH terms:
Layout table for MeSH terms
Vestibular Diseases
Labyrinth Diseases
Labyrinthitis
Bilateral Vestibulopathy
Sensation Disorders
Disease
Pathologic Processes
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Otitis