Multichannel Vestibular Implant Early Feasibility Study (NCT02725463) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Multichannel Vestibular Implant Early Feasibility Study
United States30 participantsStarted 2016-04
Plain-language 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.
Who can participate
Age range22 Years – 90 Years
SexALL
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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:
✓. 0.5/1/2/4 kHz pure-tone-average threshold (PTA) hearing better than (i.e., less than) 70 dB HL; and
✓. 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
✓. 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
✓. 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
What they're measuring
1
Identified adverse events to assess the safety and tolerability of the Labyrinth Devices Multichannel Vestibular Implant (MVI™)
Timeframe: Through study completion, an average of 1 year, that is: in visits 0 through 10
2
Assess the feasibility 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
Timeframe: Through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
3
Assess the 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
Timeframe: Through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
4
Assess the effects of MVI implantation on cochlear function, as indicated by changes in pure tone audiometry
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
5
Assess the effects of MVI use on cochlear function, as indicated by changes in pure tone audiometry
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
6
Assess the effects of MVI implantation on cochlear function, as indicated by changes in Consonant-vowel nucleus-consonant (CNC) speech recognition scores
✓. 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
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 (PCI) within 6 months prior to screening
✕. 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.
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
7
Assess the effects of MVI use on cochlear function, as indicated by changes in Consonant-vowel nucleus-consonant (CNC) speech recognition scores
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
8
Assess the effects of MVI implantation on cochlear function, as indicated by changes in Arizona Biomedical (AzBio) sentence recognition scores
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
9
Assess the effects of MVI use on cochlear function, as indicated by changes in Arizona Biomedical (AzBio) sentence recognition scores
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10