RECRUITING

Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction

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Conditions

Other Disorders of Vestibular Function, BilateralBilateral Vestibular Deficiency (BVD)Gentamicin OtotoxicityLabyrinth DiseasesVestibular DiseasesSensation DisordersBilateral Vestibular HypofunctionBilateral VestibulopathyAminoglycoside OtotoxicityVestibularimplantprosthesislabyrinthototoxicitygentamicinoscillopsiadisequilibriumdizzinessvestibulopathyinner ear

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction

Quick Facts

Study Start:2023-02-28
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05674786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults age 22-90 years diagnosed with ototoxic, idiopathic or non-ototoxic/non-central bilateral vestibular hypofunction inadequately responsive to vestibular rehabilitation for greater than 1 year as determined by pre-inclusion history, vestibular testing and clinical examination conducted by a board-certified neurotologist, neurologist or other physician skilled in diagnosis of vestibular disorders
  2. 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:
  3. 1. 0.5/1/2/4 kHz pure-tone-average threshold (PTA) hearing better than (i.e., less than) 70 dB HL; and
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 6. Vaccinations as recommended per Johns Hopkins Cochlear Implant Center and United States Centers for Disease Control and Prevention protocols to reduce the risk of meningitis in subjects undergoing cochlear implantation, as described at this site: https://www.cdc.gov/vaccines/vpd/mening/public/dis-cochlear-faq-gen.html
  10. 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
  11. 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
  1. 1. Inability to understand the procedures and the potential risks involved as determined by study staff
  2. 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. 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. 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. 5. Lack of labyrinth patency or vestibular nerve as determined by MRI of the brain with attention to the internal acoustic meatus
  6. 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. 7. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to screening
  8. 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. 9. Subjects with estimated glomerular filtration rate (GFR) \< 30 ml/min (MDRD formula) at screening
  10. 10. Subjects with heart failure NYHA class III or IV
  11. 11. Subjects with Child-Pugh class C cirrhosis
  12. 12. Inadequately treated or unstable depression, suicidality as indicated by any affirmative answer to the 6-question screener version of the Columbia Suicide Severity Rating Scale (C-SSRS), or any other psychiatric disease or substance abuse history likely to interfere with protocol compliance
  13. 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. 14. Inability to tolerate baseline testing protocols
  15. 15. Recent corneal injury
  16. 16. A history of cervical spine disease preventing head rotation
  17. 17. A history of fainting or vagal reactions prior to eye manipulations that would preclude 3D eye movement coil testing
  18. 18. Pregnancy, positive urine or serum pregnancy test at any time during study participation,
  19. 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:
  20. 20. Women who are nursing/lactating
  21. 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.

Contacts and Locations

Study Contact

Kelly Lane (Study Coordinator)
CONTACT
410-502-8047
vestibularimplant@jhmi.edu
Charles C Della Santina MD, PhD, (Lead Surgeon)
CONTACT
410-502-8047
cds@jhmi.edu

Principal Investigator

John P Carey, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine

Study Locations (Sites)

Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • John P Carey, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-28
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-02-28
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Vestibular
  • implant
  • prosthesis
  • labyrinth
  • ototoxicity
  • gentamicin
  • oscillopsia
  • disequilibrium
  • dizziness
  • vestibulopathy
  • inner ear

Additional Relevant MeSH Terms

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