Clinical trial NCT05674786: Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction
Official title: Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Keywords: Vestibular
implant
prosthesis
labyrinth
ototoxicity
gentamicin
oscillopsia
disequilibrium
dizziness
vestibulopathy
inner ear
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Labyrinth Devices, LLC
First posted: 2023-01-06
Enrollment: 8
Sex: ALL
Minimum age (years): 22
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: There is no adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to loss of semicircular canal function despite vestibular rehabilitation exercises. The experience of seven adults with bilateral vestibular hypofunction due to ototoxicity who underwent unilateral surgical placement of a vestibular implant and have received continuously motion-modulated electrical stimulation of the vestibular nerve for \>6 months revealed that this approach can partially restore vestibular sensation and reflexes that normally maintain steady posture and vision. This study will examine long-term outcomes in that cohort and extend vestibular implant treatment to adults with idiopathic or non-ototoxic/non-central bilateral vestibular hypofunction. Within constraints on power and/or minimum detectable effect size due to limits on the number of study participants permitted under IDE G150198 and U01DC019364, the study will test the following hypotheses regarding unilateral vestibular implantation, activation and long-term (≥8 week) continuous/daily use:

1. It is feasible, as quantified by implantation being achieved in all subjects undergoing attempted implantation surgery.
2. It is safe, as determined by incidence of serious unanticipated adverse device-related events and as further quantified by proportions of:

   1. implanted ears with preservation of 4-frequency pure tone average for 0.5,1,2,4 kHz air-conducted audiometric detection thresholds ≤ 50 dB HL and ear-specific speech discrimination ≥50% (consistent with Class A or B per American Academy of Otolaryngology-Head and Neck Surgery 1995 guidelines13 ) or ≤ 30 dB change from preoperative baseline (if preoperative baseline is ≥20 dBHL) and ear-specific speech discrimination ≤30% worse than preoperative baseline (if preoperative baseline is ≤80%)
   2. participants with preservation of useful sound-field hearing by the above criteria, and
   3. implanted ears with preservation of otolith endorgan function, if present pre-operatively
3. It is tolerable, as quantified by ≥6 mo duration of compliance with use.
4. It is efficacious, as defined by nonzero improvement with respect to preoperative baseline in Vestibular Implant Composite Outcome score (VICO), which incorporates vestibulo-ocular reflex gain during passive head impulse rotation (VHITG); postural stability as quantified by the Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition Balance Subtest 5 (BOT); gait stability as quantified by Dynamic Gait Index (DGI); Dizziness Handicap Inventory (DHI); and SF-6D health utility (SF6DU).

Eligibility criteria: Inclusion Criteria:

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. 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 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
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. 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. 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.

Primary outcomes:
measure: PM1.1: Dynamic Gait Index (DGI) during motion-modulated implant stimulation at 6 months post-implantation, relative to pre-operative baseline, aggregated across all implant users.
timeFrame: Pre-intervention to 6 months post-implantation
measure: PM1.2: Gain (VHITG) of the vestibulo-ocular reflex, as measured using the video head impulse test averaged for the three implanted semicircular canals, relative to pre-operative baseline, aggregated across all implant users.
timeFrame: Pre-intervention to 6 months post-implantation
Secondary outcomes:
measure: EM1.1: Vestibular Implant Composite Outcome (VICO) score at 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM1.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT) score 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM1.3: Dizziness Handicap Inventory (DHI) score at 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM1.4: SF6D utility (SF6DU) score at 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM2.1: Vestibular Implant Composite Outcome (VICO) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM2.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT) score 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM2.3: Dizziness Handicap Inventory (DHI) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM2.4: SF6D utility (SF6DU) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM2.5: Dynamic Gait Index (DGI) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM2.6: Gain (VHITG) of the vestibulo-ocular reflex, measured using the vHIT averaged for the three implanted semicircular canals, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM3.1: Vestibular Implant Composite Outcome (VICO) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM3.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT) score 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM3.3: Dizziness Handicap Inventory (DHI) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM3.4: SF6D utility (SF6DU) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM3.5: Dynamic Gait Index (DGI) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: EM3.6: Gain (VHITG) of the vestibulo-ocular reflex, measured using the video head impulse test averaged for the three implanted semicircular canals, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Pre-intervention to 6 months post-implantation
measure: SM0.1: Type of unanticipated adverse device effects as of 6 months post-implantation
timeFrame: Pre-intervention to 6 months post-implantation
measure: SM0.2: Incidence of unanticipated adverse device effects as of 6 months post-implantation
timeFrame: Pre-intervention to 6 months post-implantation
measure: SM0.3: Severity of unanticipated adverse device effects as of 6 months post-implantation
timeFrame: Pre-intervention to 6 months post-implantation
measure: SM1.1: Changes in implant-side bone-conduction 4-frequency (0.5, 1, 2, 4 kHz) pure tone average detection threshold (BonePTAi), aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.2: Changes in implant-side air-conduction 4-frequency pure tone average detection threshold (AirPTAi), aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.3: Changes in implant-side consonant-nucleus-consonant word discrimination score (CNCWi), aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.4: Changes in sound-field Arizona Biology (AzBios) sentences-in-noise discrimination score, aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.5: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preoperative baseline AirPTAi ≥ 20dBHL and CNCWi ≤ 80%, respectively, aggregating data across all implanted participants (ClassABCNCWa)
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.6: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preoperative baseline AirPTAi ≥ 20dBHL and AzBios ≤ 80%, respectively, aggregating across all implanted participants (ClassABAzBioa)
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.7: Change in implant-side ear distortion-product otoacoustic emission (DPOAE) signal-to-noise ratio for responses to tones centered on 0.75, 1, 1.5, 2, 3, 4, 6 and 8 kHz (an 8-valued vector), aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.8: Changes in implant-side tympanometry responses (a 3-valued vector comprising peak compliance in mL, pressure in decaPascals at peak admittance, and ear canal volume in mL), aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.9: Changes in Tinnitus Handicap Inventory (THI), aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.10: Changes in Autophony Index (AI), aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.11: Changes in cervical vestibular-evoked myogenic potential (cVEMP) response amplitude, aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.12: Changes in ocular vestibular-evoked myogenic potential (oVEMP) response amplitude, aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.13: Changes in subjective visual vertical (SVV) as assessed using the Bucket Test, aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.14: Changes in scalp thickness at the location of implanted magnets (Tscalp), aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM1.15: Changes in all adverse events, including but not limited to events related to the surgical procedure, device and device systems, aggregated across all implant users
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.1: Changes in implant-side bone-conduction 4-frequency (0.5, 1, 2, 4 kHz) pure tone average detection threshold (BonePTAi), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.2: Changes in implant-side air-conduction 4-frequency pure tone average detection threshold (AirPTAi), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.3: Changes in implant-side consonant-nucleus-consonant word discrimination score (CNCWi), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.4: Changes in sound-field Arizona Biology (AzBios) sentences-in-noise discrimination score, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.5: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preop baseline AirPTAi ≥ 20dBHL and CNCWi ≤ 80%, respectively, for non-ototoxic/non-central adult-onset BVH participants (ClassABCNCWn)
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.6: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preop baseline AirPTAi ≥ 20dBHL and AzBios ≤ 80%, respectively, for non-ototoxic/non-central BVH participants (ClassABAzBion)
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.7: Change in implant-side distortion-product otoacoustic emission (DPOAE) signal/noise ratio for response to tones centered on 0.75/1/1.5/2/3/4/6/8 kHz, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.8: Changes in implant-side tympanometry response (3-valued vector comprising peak admittance in mL, pressure in decaPascals at peak admittance, and ear canal volume in mL), for the participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.9: Changes in Tinnitus Handicap Inventory (THI), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.10: Changes in Autophony Index (AI), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.11: Changes in cervical vestibular-evoked myogenic potential (cVEMP) response amplitude, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.12: Changes in ocular vestibular-evoked myogenic potential (oVEMP) response amplitude, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.13: Changes in subjective visual vertical (SVV) as assessed using the Bucket Test, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.14: Changes in scalp thickness at the location of implanted magnets (Tscalp), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM2.15: Changes in all adverse events, including but not limited to events related to the surgical procedure, device and device systems, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.1: Changes in implant-side bone-conduction 4-frequency (0.5, 1, 2, 4 kHz) pure tone average detection threshold (BonePTAi), for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.2: Changes in implant-side air-conduction 4-frequency pure tone average detection threshold (AirPTAi), for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.3: Changes in implant-side consonant-nucleus-consonant word discrimination score (CNCWi), for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.4: Changes in sound-field Arizona Biology (AzBios) sentences-in-noise discrimination score, for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.5: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preoperative baseline AirPTAi ≥ 20dBHL and CNCWi ≤ 80%, respectively, aggregating across participants with ototoxic BVH (ClassABCNCWo)
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.6: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preoperative baseline AirPTAi ≥ 20dBHL and AzBios ≤ 80%, respectively, aggregating across participants with ototoxic BVH (ClassABAzBioo)
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.7: Change in implant-side distortion-product otoacoustic emission (DPOAE) signal/noise ratio for response to tones centered on 0.75/1/1.5/2/3/4/6/8 kHz, for participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.8: Changes in implant-side tympanometry responses (a 3-valued vector comprising peak compliance in mL, pressure in decaPascals at peak admittance, and ear canal volume in mL), for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.9: Changes in Tinnitus Handicap Inventory (THI), for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.10: Changes in Autophony Index (AI), for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.11: Changes in cervical vestibular-evoked myogenic potential (cVEMP) response amplitude, for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.12: Changes in ocular vestibular-evoked myogenic potential (oVEMP) response amplitude, for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.13: Changes in subjective visual vertical (SVV) as assessed using the Bucket Test, for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.14: Changes in scalp thickness at the location of implanted magnets (Tscalp), for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: SM3.15: Changes in all adverse events, including but not limited to events related to the surgical procedure, device and device systems, for the subgroup of participants who have ototoxic adult-onset BVH
timeFrame: Preoperative baseline to 6 month post-operative assessment
measure: TM1: Proportion of all implanted participants who continue to use the MVI system daily at 6 months post-implantation
timeFrame: 6 month post-operative assessment
measure: TM2: Proportion of implanted participants with non-ototoxic/non-central adult-onset BVH who continue to use the MVI system daily at 6 months post-implantation
timeFrame: 6 month post-operative assessment
measure: TM3: Proportion of implanted participants with ototoxic adult-onset BVH who continue to use the MVI system daily at 6 months post-implantation
timeFrame: 6 month post-operative assessment
Other outcomes:
measure: XM1.1 (A,B,C): Change in vestibulo-ocular reflex (VOR) latency (msec) during video head impulse testing (VHIT) at 6 months post-implantation, relative to preoperative baseline values
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM1.2 (A,B,C): Change in saccade latency (msec) during video head impulse testing (VHIT) at 6 months post-implantation, relative to preoperative baseline values
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM2.1 (A,B,C): Change in vestibulo-ocular reflex (VOR) gain-time constant product (GainTc) during whole-body yaw rotary chair velocity step rotations toward the implanted ear at 6 months post-implantation, relative to preoperative baseline values
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM2.2 (A,B,C): Change in vestibulo-ocular reflex response for whole-body yaw sinusoidal rotation at peak velocity 100 deg/s and 0.05/0.1/0.2/0.5/1 Hz, with study device in modes A (motion-modulated/treatment), B (constant/placebo) and C (off)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM3.1: Electrically-evoked vestibulo-ocular reflex (eeVOR) response peak magnitude for largest response on each electrode
timeFrame: Measured at 6-month post-operative assessment
measure: XM3.2: Electrically-evoked vestibulo-ocular reflex (eeVOR) response 3D misalignment for largest response on each electrode
timeFrame: Measured at 6-month post-operative assessment
measure: XM4 (A,B,C): Change in objective measures of time to failure on Modified Romberg Test with Eyes Closed on Foam
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM5.1 (A,B,C): (A,B,C): Change in slope of change in treadmill dynamic visual acuity with increasing walking speed (logMAR/mph)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM5.2 (A,B,C): Change in maximum treadmill velocity achieved
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM6.1 (A,B,C): Change in gait speed when walking in well-light hall
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM6.2 (A,B,C): Change in gait speed when walking in dim light
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM7.1 (A,B,C): Change in Timed Up and Go test (TUG) when walking in well-lit hall
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM7.2 (A,B,C): Change in Timed Up and Go test (TUG) when walking in dim light
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM8.1 (A,B,C): Change in gait speed when walking during dual task/cognitive distraction (Serial 7s downward counting)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM8.2 (A,B,C): Change in Timed Up and Go test (TUG) during dual task/cognitive distraction (Serial 7s)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM9 (A,B,C): Change in Serial 7s downward counting while standing with eyes open
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM10.1 (A,B,C): Change in time to complete the Trail Making Test Part B (TMT)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM10.2 (A,B,C): Change in performance on the Triangle Completion Test (TCT)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM11: Electrode impedance
timeFrame: Initial post-activation measurement to 6-month post-operative assessment
measure: XM12: Change in electrode location, as determined by post-implantation computed tomography (CT) imaging
timeFrame: Single measurement 3 weeks post-implantation
measure: XM13: Amplitude of vestibular evoked compound action potential (veCAP)
timeFrame: Single measurement 3 weeks post-implantation
measure: XM14.1: Scalp thickness over the implant, measured on post-operative CT imaging
timeFrame: Single measurement 3 weeks post-implantation
measure: XM14.2: Change in inductively-measured intercoil distance between implant antenna coil and external processor antenna coil
timeFrame: Change from 3 weeks post-implantation to 6 months post-implantation
measure: XM15.1: Change in Bilateral Vestibulopathy Questionnaire score (BVQ)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM15.2: Audio/video recording of structured interviews
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM16: Change in Vestibular Activities of Daily Living score (VADL)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM17 (A,B,C): Change in Oscillopsia Visual Analog Scale score (oVAS)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM18: Change in Activities-specific Balance Confidence Scale score (ABC)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM19.1: Change in Vertigo Symptom Scale score (VSS)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM19.2: Change in Vertigo Visual Analogue Scale score (VAS)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM20.1: Change in Health Utilities Index Mark 3 (HUI)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM20.2: Change in EuroQOL EQ5D score
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM21: Change in Tinnitus Handicap Inventory (THI)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM22: Change in Autophony Index (AI)
timeFrame: Preoperative baseline to 6-month post-operative assessment
measure: XM23.1: OTOSCOPE genetic testing panel screen for participants who agree to genetic testing
timeFrame: Single measurement at preoperative baseline
measure: XM23.2: MTRNR1 genetic test panel screen for participants with known ototoxic exposure who agree to genetic testing
timeFrame: Single measurement at preoperative baseline
measure: XM24.1: intraoperative video recording of electrode implantation
timeFrame: Single recording intraoperatively
measure: XM24.2: post-implantation temporal bone CT imaging
timeFrame: Single measurement 3 weeks post-implantation
measure: XM25: Change in study visit duration by activity/test/assessment
timeFrame: Preoperative baseline to 6-month post-operative assessment
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: John P Carey, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sun DQ, Ward BK, Semenov YR, Carey JP, Della Santina CC. Bilateral Vestibular Deficiency: Quality of Life and Economic Implications. JAMA Otolaryngol Head Neck Surg. 2014 Jun;140(6):527-34. doi: 10.1001/jamaoto.2014.490.
citation: Mitchell DE, Dai C, Rahman MA, Ahn JH, Della Santina CC, Cullen KE. Head movements evoked in alert rhesus monkey by vestibular prosthesis stimulation: implications for postural and gaze stabilization. PLoS One. 2013 Oct 17;8(10):e78767. doi: 10.1371/journal.pone.0078767. eCollection 2013.
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citation: Hedjoudje A, Schoo DP, Ward BK, Carey JP, Della Santina CC, Pearl M. Vestibular Implant Imaging. AJNR Am J Neuroradiol. 2021 Jan;42(2):370-376. doi: 10.3174/ajnr.A6991. Epub 2020 Dec 24.
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citation: Boutros PJ, Schoo DP, Rahman M, Valentin NS, Chow MR, Ayiotis AI, Morris BJ, Hofner A, Rascon AM, Marx A, Deas R, Fridman GY, Davidovics NS, Ward BK, Trevino C, Bowditch SP, Roberts DC, Lane KE, Gimmon Y, Schubert MC, Carey JP, Jaeger A, Della Santina CC. Continuous vestibular implant stimulation partially restores eye-stabilizing reflexes. JCI Insight. 2019 Nov 14;4(22):e128397. doi: 10.1172/jci.insight.128397.