Clinical trial: Multichannel Vestibular Implant Early Feasibility Study (NCT02725463)

Eligibility 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.htm
             l

          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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
Subject must be at most 90 Years

Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? Entailment