Long Term Outcomes After Vestibular Implantation
Overview
- Phase
- N/A
- Intervention
- Labyrinth Devices MVI™ Multichannel Vestibular Implant System
- Conditions
- Bilateral Vestibular Hypofunction
- Sponsor
- Johns Hopkins University
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- PM1.2: Gain (VHITG) of the vestibulo-ocular reflex (VOR), as measured using the video head impulse test (vHIT)
- Status
- Recruiting
- Last Updated
- last month
Overview
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 widely available, 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 15 adults with bilateral vestibular hypofunction 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 vestibular implantation (VI) and motion-modulated stimulation can partially restore vestibular sensation and reflexes that normally maintain steady posture and vision. This study will examine long-term outcomes after vestibular implantation. Within constraints on power and/or minimum detectable effect size due to limits on the number of study participants permitted under IDE G150198, the study will test the following hypotheses regarding unilateral vestibular implantation, activation and long-term (≥3 years) continuous/daily use: 1. 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 decibel (dB) HL and ear-specific speech discrimination ≥50% (consistent with Class A or B per American Academy of Otolaryngology-Head and Neck Surgery 1995 guidelines 13 ) 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 2. It is tolerable, as quantified by duration of compliance with use. 3. It is efficacious, as defined by nonzero improvement with respect to preoperative baseline gait stability as quantified by Dynamic Gait Index (DGI) and vestibulo-ocular reflex gain during passive head impulse rotation (VHITG) .
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults older than 22 years old who
- •have previously been enrolled in Johns Hopkins University Institutional Review Board protocol NA\_00051349, IRB00335294 or IRB00346924 and
- •have previously been implanted with a vestibular implant under FDA IDE G150198
Exclusion Criteria
- Not provided
Arms & Interventions
Vestibular Implant
Up to 32 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System (MVI)
Intervention: Labyrinth Devices MVI™ Multichannel Vestibular Implant System
Outcomes
Primary Outcomes
PM1.2: Gain (VHITG) of the vestibulo-ocular reflex (VOR), as measured using the video head impulse test (vHIT)
Time Frame: 4 years post-implantation up to 5 years post-enrollment
During video head impulse testing (vHIT), rotational eye and head movement are measured by a goggle-mounted camera and motion sensor during brief, fast \~10 degree head rotations about the axis of a semicircular canal being tested. Performance is quantified by vestibulo-ocular reflex (VOR) gain, which a ratio of eye movement to head movement (in this case the integral of eye velocity relative to the head and the additive inverse of the integral of head velocity, respectively). VHITG, the average vHIT VOR gain for each of the three semicircular canals of the implanted ear, typically ranges from 0 to 1, with higher numbers indicating better performance.
PM1.1: Dynamic Gait Index (DGI)18 during motion-modulated implant stimulation at 4 years post-implantation, relative to pre-operative baseline, aggregated across all implant users.
Time Frame: 4 years post-implantation up to 5 years post-enrollment
DGI comprises 8 gait tasks scored by an examiner: walking on a level surface, changing gait speed, walking during horizontal head turns, walking during vertical head turns, pivoting, stepping over an obstacle, stepping around obstacles, and waling up and down stairs. Each task is scored (0-3 points, 3 is best). Raw DGI score is the sum of the eight subtest scores and ranges from 0 to 24, with higher scores meaning better outcome and minimally important difference 3.2 points.
Secondary Outcomes
- EM2.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT)(4 years post-implantation up to 5 years post-enrollment)
- EM3.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT) score 4 years post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH.(4 years post-implantation up to 5 years post-enrollment)
- EM1.4: SF6D utility (SF6DU) score(4 years post-implantation up to 5 years post-enrollment)
- EM2.1: Vestibular Implant Composite Outcome (VICO) score(4 years post-implantation up to 5 years post-enrollment)
- EM2.3: Dizziness Handicap Inventory (DHI)(4 years post-implantation up to 5 years post-enrollment)
- EM1.1: Vestibular Implant Composite Outcome (VICO) score(4 years post-implantation up to 5 years post-enrollment)
- EM1.3: Dizziness Handicap Inventory (DHI)(4 years post-implantation up to 5 years post-enrollment)
- EM1.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT) score.(4 years post-implantation up to 5 years post-enrollment)
- EM3.5: Dynamic Gait Index (DGI) score at 4 years post-implantation, relative to pre-operative.baseline, for the subgroup of participants who have ototoxic adult-onset BVH.(4 years post-implantation up to 5 years post-enrollment)
- SM0: Type, incidence and severity of unanticipated adverse device effects as of 4 years post-implantation(4 years post-implantation up to 5 years post-enrollment)
- SM1.2: implant-side air-conduction 4-frequency pure tone average detection threshold (AirPTAi)(4 years post-implantation up to 5 years post-enrollment)
- SM1.4: sound-field Arizona Biology (AzBios)27 sentences-in-noise discrimination score(4 years post-implantation up to 5 years post-enrollment)
- SM1.12: ocular vestibular-evoked myogenic potential (oVEMP) response amplitude(4 years post-implantation up to 5 years post-enrollment)
- TM2: Proportion of implanted participants with non-ototoxic/non-central adult-onset BVH who continue to use the MVI system daily at 4 years post-implantation(4 years post-implantation up to 5 years post-enrollment)
- EM2.4: SF6D utility (SF6DU) score(4 years post-implantation up to 5 years post-enrollment)
- EM2.5: Dynamic Gait Index (DGI)(4 years post-implantation up to 5 years post-enrollment)
- EM3.1: Vestibular Implant Composite Outcome (VICO) score at 4 years post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH.(4 years post-implantation up to 5 years post-enrollment)
- SM1.6: Proportion of implanted participants who maintain AAO-HNS 1995 Class A or B hearing or ≤ 30 dB change from preoperative baseline (if preoperative baseline is ≥20 dBHL) and ear-specific speech discrimination ≤30% worse than preoperative baseline(4 years post-implantation up to 5 years post-enrollment)
- SM1.8: Ear canal acoustic admittance as assessed by implant-side tympanometry(4 years post-implantation up to 5 years post-enrollment)
- SM1.9: Tinnitus Handicap Inventory (THI)(4 years post-implantation up to 5 years post-enrollment)
- EM2.6: Gain (VHITG) of the vestibulo-ocular reflex (VOR), as measured using the video head impulse test (vHIT) and averaged for the three implanted semicircular canals(4 years post-implantation up to 5 years post-enrollment)
- EM3.3: Dizziness Handicap Inventory (DHI) score at 4 years post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH.(4 years post-implantation up to 5 years post-enrollment)
- SM1.11: cervical vestibular-evoked myogenic potential (cVEMP) response amplitude(4 years post-implantation up to 5 years post-enrollment)
- SM1.14: scalp thickness at the location of implanted magnets (Tscalp)(4 years post-implantation up to 5 years post-enrollment)
- TM1: Proportion of all implanted participants who continue to use the MVI system daily at 4 years post-implantation(4 years post-implantation up to 5 years post-enrollment)
- EM3.4: SF6D utility (SF6DU) score at 4 years post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH.(4 years post-implantation up to 5 years post-enrollment)
- 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.(4 years post-implantation up to 5 years post-enrollment)
- SM1.13: subjective visual vertical (SVV) as assessed using the Bucket Test(4 years post-implantation up to 5 years post-enrollment)
- SM1.15: all adverse events, including but not limited to events related to the surgical procedure, device and device systems(4 years post-implantation up to 5 years post-enrollment)
- TM3: Proportion of implanted participants with ototoxic adult-onset BVH who continue to use the MVI system daily at 4 years post-implantation(4 years post-implantation up to 5 years post-enrollment)
- SM1.1: implant-side bone-conduction 4-frequency (0.5, 1, 2, 4 kHz) pure tone average detection threshold (BonePTAi)(4 years post-implantation up to 5 years post-enrollment)
- SM1.3: implant-side consonant-nucleus-consonant word discrimination score (CNCWi)(4 years post-implantation up to 5 years post-enrollment)
- SM1.5: Proportion of implanted ears that maintain American Academy of Otolaryngology - Head & Neck Surgery (AAO-HNS) 1995 Class A or B hearing13 or ≤ 30 dB change from preoperative baseline (if preoperative baseline is ≥20 dBHL) and ear-specific speech(4 years post-implantation up to 5 years post-enrollment)
- SM1.7: implant-side distortion-product otoacoustic emissions(4 years post-implantation up to 5 years post-enrollment)
- SM1.10: Autophony Index (AI)(4 years post-implantation up to 5 years post-enrollment)