Bilateral Vestibular HypofunctionNCT06500975
Long Term Outcomes After Vestibular Implantation
A study testing Labyrinth Devices MVI™ Multichannel Vestibular Implant System in people with Bilateral Vestibular Hypofunction and Bilateral Vestibular Deficiency, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 90 years
- Conditions the study is for
- Bilateral Vestibular Hypofunction, Bilateral Vestibular Deficiency, Bilateral Vestibulopathy
- What is being tested?
- Labyrinth Devices MVI™ Multichannel Vestibular Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Lauren N Trainer, BS, 410-502-5129, vestibularimplant@jhmi.edu
Charles C Della Santina, MDPhD, 410-502-8047, vestibularimplant@jhmi.edu
About this study
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.
Read the 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:
- It is safe, as determined by incidence of serious unanticipated adverse device-related events and as further quantified by proportions of:
- 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%)
- participants with preservation of useful sound-field hearing by the above criteria, and
- implanted ears with preservation of otolith endorgan function, if present pre-operatively
- It is tolerable, as quantified by duration of compliance with use.
- 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) .
- Conditions
- Bilateral Vestibular Hypofunction, Bilateral Vestibular Deficiency, Bilateral Vestibulopathy, Gentamicin Ototoxicity, Aminoglycoside Toxicity, Vestibular Diseases
- Being tested
- Labyrinth Devices MVI™ Multichannel Vestibular Implant System
- Keywords
- Vestibular, Implant, Prosthesis, Labyrinth, Ototoxicity, Gentamicin, Oscillopsia, Disequilibrium, Dizziness, Vestibulopathy, Inner Ear
- Medical subject headings
- Bilateral Vestibulopathy, Vestibular Diseases, Sensation Disorders, Labyrinth Diseases, Ototoxicity, Dysequilibrium syndrome, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labyrinth Devices MVI™ Multichannel Vestibular Implant SystemDevice
Also called Motion-modulated stimulation delivered by a vestibular implant already implanted under a prior study protocol
Continuously motion-modulated stimulation delivered by a vestibular implant already implanted under a prior study protocol (Labyrinth Devices MVI™ Multichannel Vestibular Implant System)
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Implant | Experimental | Up to 32 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System (MVI) Receives: Device: Labyrinth Devices MVI™ Multichannel Vestibular Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 4 years post-implantation up to 5 years post-enrollment
PM1.2: Gain (VHITG) of the vestibulo-ocular reflex (VOR), as measured using the video head impulse test (vHIT)
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.
Measured: 4 years post-implantation up to 5 years post-enrollment
Secondary outcomes (35)
EM1.1: Vestibular Implant Composite Outcome (VICO) score
Vestibular Implant Composite Outcome (VICO) score incorporates changes in vestibulo-ocular reflex gain during video head impulse testing, postural stability, gait, dizziness handicap, and health-related quality of life at 4 years post-implantation, relative to pre-operative baseline. VICO (t=6months post-op) score is the sum of changes, from preoperative baseline to 4 years post-implantation, in 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 SF6D health utility (SF6DU); with each component's contribution scaled to the corresponding test's minimally important difference (MID). Score 0-100, higher scores indicate better outcomes.
Measured: 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.
BOT comprises 9 postural tasks scored by an examiner: standing with both feet on a line, standing on one leg, tandem walking, walking on a line with eyes open and eyes closed, and standing on a balance beam. Each task is performed twice and scored (0-4 points, 4 is best). The BOT score is the sum of the best scores for each task. It ranges from 0 to 36 points, with higher scores meaning better outcome and minimally important difference 4.5 points.
Measured: 4 years post-implantation up to 5 years post-enrollment
EM1.3: Dizziness Handicap Inventory (DHI)
Dizziness Handicap Inventory (DHI) is a 25-question survey designed to quantify self-rated disability due to dizziness and unsteadiness, with scores ranging from 0 (least disabled, best outcome) to 100 (worst outcome). The minimally important difference is 18 points.
Measured: 4 years post-implantation up to 5 years post-enrollment
EM1.4: SF6D utility (SF6DU) score
SF6DU is a unitless health utility score computed from patient-reported replies to the SF6 health-related quality of life survey and ranging from 0 to 1, with higher scores meaning better outcome and minimally important difference 0.03 points.
Measured: 4 years post-implantation up to 5 years post-enrollment
EM2.1: Vestibular Implant Composite Outcome (VICO) score
Vestibular Implant Composite Outcome (VICO) score incorporates changes in vestibulo-ocular reflex gain during video head impulse testing, postural stability, gait, dizziness handicap, and health-related quality of life at 4 years post-implantation, relative to pre-operative baseline. VICO (t=6months post-op) score is the sum of changes, from preoperative baseline to 4 years post-implantation, in 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 SF6D health utility (SF6DU); with each component's contribution scaled to the corresponding test's minimally important difference (MID). Score 0-100, higher scores indicate better outcomes.
Measured: 4 years post-implantation up to 5 years post-enrollment
EM2.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT)
BOT includes 9 postural tasks scored by an examiner: standing with both feet on a line, standing on one leg, tandem walking, walking on a line with eyes open and eyes closed, and standing on a balance beam. Each task is performed twice and scored (0-4 points). The BOT score is the sum of the best scores for each task. It ranges from 0 to 36 points, with higher scores meaning better outcome and minimally important difference 4.5 points.
Measured: 4 years post-implantation up to 5 years post-enrollment
EM2.3: Dizziness Handicap Inventory (DHI)
Dizziness Handicap Inventory (DHI) is a 25-question survey designed to quantify self-rated disability due to dizziness and unsteadiness, with scores ranging from 0 (least disabled, best outcome) to 100 (worst outcome). The minimally important difference is 18 points.
Measured: 4 years post-implantation up to 5 years post-enrollment
EM2.4: SF6D utility (SF6DU) score
SF6DU is a unitless health utility score computed from patient-reported replies to the SF6 health-related quality of life survey and ranging from 0 to 1, with higher scores meaning better outcome and minimally important difference 0.03 points.
Measured: 4 years post-implantation up to 5 years post-enrollment
EM2.5: Dynamic Gait Index (DGI)
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.
Measured: 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
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.
Measured: 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.
Vestibular Implant Composite Outcome (VICO) score incorporates changes in vestibulo-ocular reflex gain during video head impulse testing, postural stability, gait, dizziness handicap, and health-related quality of life at 4 years post-implantation, relative to pre-operative baseline. VICO (t=6months post-op) score is the sum of changes, from preoperative baseline to 4 years post-implantation, in 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 SF6D health utility (SF6DU); with each component's contribution scaled to the corresponding test's minimally important difference (MID). Score 0-100, higher scores indicate better outcomes.
Measured: 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.
BOT includes 9 postural tasks scored by an examiner: standing with both feet on a line, standing on one leg, tandem walking, walking on a line with eyes open and eyes closed, and standing on a balance beam. Each task is performed twice and scored (0-4 points). The BOT score is the sum of the best scores for each task. It ranges from 0 to 36 points, with higher scores meaning better outcome and minimally important difference 4.5 points.
Measured: 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.
Dizziness Handicap Inventory (DHI) is a 25-question survey designed to quantify self-rated disability due to dizziness and unsteadiness, with scores ranging from 0 (least disabled, best outcome) to 100 (worst outcome). The minimally important difference is 18 points.
Measured: 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.
SF6DU is a unitless health utility score computed from patient-reported replies to the SF6 health-related quality of life survey and ranging from 0 to 1, with higher scores meaning better outcome and minimally important difference 0.03 points.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
Assess safety of the intervention, aggregating data across all implanted participants (diversified across ototoxic and non-ototoxic/non-central adult-onset BVH), as determined by incidence of adverse device-related events from pre-intervention to 4 years post-implantation.
Measured: 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)
BonePTAi is the 4-frequency average of pure tone detection thresholds, in dBHL, for implant-side bone-conduction presentation of pure tones at 0.5, 1, 2 and 4 kHz. Range is -10 to 80 dBHL, with change toward smaller absolute values representing better (closer to normal) outcome.
Measured: 4 years post-implantation up to 5 years post-enrollment
SM1.2: implant-side air-conduction 4-frequency pure tone average detection threshold (AirPTAi)
AirPTAi is the 4-frequency average of pure tone detection thresholds, in dBHL, for implant-side air-conduction presentation of pure tones at 0.5, 1, 2 and 4 kHz. Range is -10 to 120 dBHL, with change toward smaller absolute values representing better (closer to normal) outcome.
Measured: 4 years post-implantation up to 5 years post-enrollment
SM1.3: implant-side consonant-nucleus-consonant word discrimination score (CNCWi)
CNCWi is the percentage of monosyllabic consonant-nucleus-consonant words correctly repeated when presented via an earphone speaker on the implanted side in a sound-isolation booth while a masking noise is played to the contralateral ear at 40 dB above its bone-conduction 4-frequency pure tone detection threshold if that threshold is at least 10 dB better than that of the ear being tested. CNCWi ranges from 0-100% correct, with higher score meaning better outcome.
Measured: 4 years post-implantation up to 5 years post-enrollment
SM1.4: sound-field Arizona Biology (AzBios)27 sentences-in-noise discrimination score
AzBios is the percentage of words correctly repeated when a set of 20 Arizona Biology sentences (randomly chosen without repeats from 15 sets) is presented at a moderate level (60 dB SPL) along with masking noise (simultaneous presentation of ten sentences from another set at aggregate sound level 55 dBSPL) to both ears via a sound field speaker in a sound-isolation booth. Scores range from 0-100% correct, with higher score meaning better outcome.
Measured: 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
For ClassABCNCW, AAO-HNS (American Academy of Otolaryngology - Head \& Neck Surgery) 1995 Class A or B hearing is defined as AirPTAi not worse than 50 dBHL and CNCWi not worse than 50%. ClassABCNCW proportion ranges from 0-100%, with higher values meaning better outcomes.
Measured: 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
For ClassABAzBio, AAO-HNS (American Academy of Otolaryngology - Head \& Neck Surgery) 1995 Class A or B hearing is defined as AirPTAi not worse than 50 dBHL and sound-field-presentation Arizona Biology sentences-in-noise discrimination score (AzBios) not worse than 50%. ClassABAzBio proportion ranges from 0-100%, with higher values meaning better outcomes.
Measured: 4 years post-implantation up to 5 years post-enrollment
SM1.7: implant-side distortion-product otoacoustic emissions
Distortion-product otoacoustic emissions (DPOAE) are sounds generated by a normal cochlea and detectable using a microphone in the ear canal when pairs of pure tones (centered on 0.75, 1, 1.5, 2, 3, 4, 6 and 8 kHz) are presented to the ear. DPOAE signals (and 8-valued vector for responses to stimuli centered on 0.75, 1, 1.5, 2, 3, 4, 6 and 8 kHz) are quantified in dB relative to the frequency-specific noise floor recorded by the same microphone before onset of stimulation. Response range is 0-15 dB, with higher values meaning better outcome.
Measured: 4 years post-implantation up to 5 years post-enrollment
SM1.8: Ear canal acoustic admittance as assessed by implant-side tympanometry
Tympanometry involves using an ear canal microphone to measure ear canal acoustic admittance (conventionally reported in units of mL) and volume (in mL) by sensing reflection of a 226 Hz tone presented via a speaker in the ear canal while ear canal pressure is slowly varied from -400 to 200 decaPascals. Negative bias pressures pull the ear drum outward, positive bias pressures push the ear drum inward, and acoustic admittance is greatest when the ear drum is in a neutral anatomic position, neither retracted inward nor ballooned outward. Results are conventionally represented graphically then summarized by a three-valued vector comprising peak compliance (range 0-2 milliliters (mL), values closer to normal range of 0.3-1.4 mL meaning more normal outcome), pressure at which compliance peaks (range -400 to 200 decaPascal, values closer to 0 meaning more normal outcome), and ear canal volume (range 0-3 mL, values closer to normal adult range of 0.6-1.4 meaning more normal outcome).
Measured: 4 years post-implantation up to 5 years post-enrollment
SM1.9: Tinnitus Handicap Inventory (THI)
The Tinnitus Handicap Inventory (THI) survey is set of questions designed to quantify self-perceived handicap due to tinnitus. THI score ranges from 0-100. Higher scores mean worse outcome.
Measured: 4 years post-implantation up to 5 years post-enrollment
SM1.10: Autophony Index (AI)
The Autophony Index (AI) survey is set of questions designed to quantify self-perceived autophony (hearing one's voice or other internally-generated body sounds). AI score ranges from 0-104. Higher scores mean worse outcomes.
Measured: 4 years post-implantation up to 5 years post-enrollment
SM1.11: cervical vestibular-evoked myogenic potential (cVEMP) response amplitude
Cervical vestibular-evoked myogenic potentials (cVEMPs) are a measure of saccule-mediated inhibition of sternocleidomastoid muscle electromyographic (EMG) activity during presentation of loud tones to the ipsilateral ear. After normalizing to average rectified EMG activity (in microvolts) prior to sound stimulation, cVEMP amplitudes (in microvolts) are unitless. Values range from 0 to ~10, with larger values suggesting increased saccule activity and generally indicating better outcomes, except that values above 3.0 suggest abnormally high saccule sensitivity to sound.
Measured: 4 years post-implantation up to 5 years post-enrollment
SM1.12: ocular vestibular-evoked myogenic potential (oVEMP) response amplitude
Ocular vestibular-evoked myogenic potentials (oVEMPs) are a measure of utricle-mediated electromyographic (EMG) activity of inferior oblique and inferior rectus extraocular muscles during presentation of loud tones to the contralateral ear. Amplitude ranges from 0 to ~50 microvolts, with larger values generally suggesting increased utricle activity and better outcomes but values above 17 microvolts suggesting abnormally high utricle sensitivity to sound.
Measured: 4 years post-implantation up to 5 years post-enrollment
SM1.13: subjective visual vertical (SVV) as assessed using the Bucket Test
A participant's vision is occluded by a bucket oriented so that its axis aligns with the participant's nasooccipital axis. The examiner rotates the bucket about the axis to a new orientation, the participant reorients it until a line drawn on the floor of the bucket is judges by the participant to be Earth-vertical and deviation of that line from true vertical is recorded. Values range over -15 to 15 degrees, with smaller absolute values meaning more normal outcomes.
Measured: 4 years post-implantation up to 5 years post-enrollment
SM1.14: scalp thickness at the location of implanted magnets (Tscalp)
Scalp thickness at the location of implanted magnets (Tscalp) is measured in mm using a magnetic sensor. Range is 0 to 10 mm, with values closer to the range 3-7mm indicating better outcomes.
Measured: 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
Assess safety of the intervention, aggregating data across all implanted participants (diversified across ototoxic and non-ototoxic/non-central adult-onset BVH), as determined by changes in hearing and otolith endorgan function indicated by changes in all adverse events, including but not limited to events related to the surgical procedure, device and device systems.
Measured: 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
Assess tolerance of the intervention, aggregating data across all implanted participants, as determined by the proportion of all implant recipients who continue to use the MVI system daily at 4 years post-implantation.
Measured: 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
Assess tolerance of the intervention, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH, as determined by the 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.
Measured: 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
Assess tolerance of the intervention, for the subgroup of participants who have ototoxic adult-onset BVH, as determined by the proportion of implanted participants with ototoxic adult-onset BVH who continue to use the MVI system daily at 4 years post-implantation.
Measured: 4 years post-implantation up to 5 years post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Dec 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Bilateral Vestibular HypofunctionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute on Deafness and Other Communication Disorders (NIDCD), Labyrinth Devices, LLC
- Responsible party
- Sponsor
- Investigators
- John P Carey, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500975
- Sponsor's protocol ID
- IRB00434328
- Status last verified
- Mar 2026
- First submitted
- 8 Jul 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Publication of de-identified data via peer-reviewed journals.
Publications
Sun DQ, Lehar M, Dai C, Swarthout L, Lauer AM, Carey JP, Mitchell DE, Cullen KE, Della Santina CC. Histopathologic Changes of the Inner ear in Rhesus Monkeys After Intratympanic Gentamicin Injection and Vestibular Prosthesis Electrode Array Implantation. J Assoc Res Otolaryngol. 2015 Jun;16(3):373-87. doi: 10.1007/s10162-015-0515-y. Epub 2015 Mar 20.
PubMed 25790951Sun 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.
PubMed 24763518Mitchell 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.
PubMed 24147142Dai C, Fridman GY, Chiang B, Rahman MA, Ahn JH, Davidovics NS, Della Santina CC. Directional plasticity rapidly improves 3D vestibulo-ocular reflex alignment in monkeys using a multichannel vestibular prosthesis. J Assoc Res Otolaryngol. 2013 Dec;14(6):863-77. doi: 10.1007/s10162-013-0413-0. Epub 2013 Sep 8.
PubMed 24013822Ward BK, Agrawal Y, Hoffman HJ, Carey JP, Della Santina CC. Prevalence and impact of bilateral vestibular hypofunction: results from the 2008 US National Health Interview Survey. JAMA Otolaryngol Head Neck Surg. 2013 Aug 1;139(8):803-10. doi: 10.1001/jamaoto.2013.3913.
PubMed 23949355Valentin NS, Hageman KN, Dai C, Della Santina CC, Fridman GY. Development of a multichannel vestibular prosthesis prototype by modification of a commercially available cochlear implant. IEEE Trans Neural Syst Rehabil Eng. 2013 Sep;21(5):830-9. doi: 10.1109/TNSRE.2013.2259261. Epub 2013 May 1.
PubMed 23649285Davidovics NS, Rahman MA, Dai C, Ahn J, Fridman GY, Della Santina CC. Multichannel vestibular prosthesis employing modulation of pulse rate and current with alignment precompensation elicits improved VOR performance in monkeys. J Assoc Res Otolaryngol. 2013 Apr;14(2):233-48. doi: 10.1007/s10162-013-0370-7. Epub 2013 Jan 26.
PubMed 23355001Fridman GY, Della Santina CC. Progress toward development of a multichannel vestibular prosthesis for treatment of bilateral vestibular deficiency. Anat Rec (Hoboken). 2012 Nov;295(11):2010-29. doi: 10.1002/ar.22581. Epub 2012 Oct 8.
PubMed 23044664Rahman MA, Dai C, Fridman GY, Davidovics NS, Chiang B, Ahn J, Hayden R, Melvin TA, Sun DQ, Hedjoudje A, Della Santina CC. Restoring the 3D vestibulo-ocular reflex via electrical stimulation: the Johns Hopkins multichannel vestibular prosthesis project. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:3142-5. doi: 10.1109/IEMBS.2011.6090857.
PubMed 22255006Dai C, Fridman GY, Davidovics NS, Chiang B, Ahn JH, Della Santina CC. Restoration of 3D vestibular sensation in rhesus monkeys using a multichannel vestibular prosthesis. Hear Res. 2011 Nov;281(1-2):74-83. doi: 10.1016/j.heares.2011.08.008. Epub 2011 Aug 26.
PubMed 21888961Dai C, Fridman GY, Chiang B, Davidovics NS, Melvin TA, Cullen KE, Della Santina CC. Cross-axis adaptation improves 3D vestibulo-ocular reflex alignment during chronic stimulation via a head-mounted multichannel vestibular prosthesis. Exp Brain Res. 2011 May;210(3-4):595-606. doi: 10.1007/s00221-011-2591-5. Epub 2011 Mar 4.
PubMed 21374081Dai C, Fridman GY, Della Santina CC. Effects of vestibular prosthesis electrode implantation and stimulation on hearing in rhesus monkeys. Hear Res. 2011 Jul;277(1-2):204-10. doi: 10.1016/j.heares.2010.12.021. Epub 2010 Dec 31.
PubMed 21195755Della Santina CC. Regaining balance with bionic ears. Sci Am. 2010 Apr;302(4):68-71. doi: 10.1038/scientificamerican0410-68. No abstract available.
PubMed 20349578Fridman GY, Davidovics NS, Dai C, Migliaccio AA, Della Santina CC. Vestibulo-ocular reflex responses to a multichannel vestibular prosthesis incorporating a 3D coordinate transformation for correction of misalignment. J Assoc Res Otolaryngol. 2010 Sep;11(3):367-81. doi: 10.1007/s10162-010-0208-5. Epub 2010 Feb 23.
PubMed 20177732Della Santina CC, Migliaccio AA, Patel AH. A multichannel semicircular canal neural prosthesis using electrical stimulation to restore 3-d vestibular sensation. IEEE Trans Biomed Eng. 2007 Jun;54(6 Pt 1):1016-30. doi: 10.1109/TBME.2007.894629.
PubMed 17554821
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes After Vestibular Implantation
- ClinicalTrials.gov ID
- NCT06500975
- Acronym / sponsor ID
- IRB00434328
- Conditions
- Bilateral Vestibular Hypofunction, Bilateral Vestibular Deficiency, Bilateral Vestibulopathy, Gentamicin Ototoxicity, Aminoglycoside Toxicity, Vestibular Diseases
- Keywords
- Vestibular, Implant, Prosthesis, Labyrinth, Ototoxicity, Gentamicin, Oscillopsia, Disequilibrium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute on Deafness and Other Communication Disorders (NIDCD), Labyrinth Devices, LLC
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- It is safe, as determined by incidence of serious unanticipated adverse device-related events and as further quantified by proportions of:
- 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%)
- participants with preservation of useful sound-field hearing by the above criteria, and
- implanted ears with preservation of otolith endorgan function, if present pre-operatively
- It is tolerable, as quantified by duration of compliance with use.
- 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) .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vestibular Implant | Experimental | Device: Labyrinth Devices MVI™ Multichannel Vestibular Implant SystemUp to 32 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System (MVI) |
Who may qualify
- Ages
- 22 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labyrinth Devices MVI™ Multichannel Vestibular Implant SystemAlso: Motion-modulated stimulation delivered by a vestibular implant already implanted under a prior study protocolContinuously motion-modulated stimulation delivered by a vestibular implant already implanted under a prior study protocol (Labyrinth Devices MVI™ Multichannel Vestibular Implant System) | Device | Vestibular Implant |
Primary outcome
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.
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.
35 secondary outcomes
EM1.1: Vestibular Implant Composite Outcome (VICO) score
Time frame: 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.
Time frame: 4 years post-implantation up to 5 years post-enrollment
EM1.3: Dizziness Handicap Inventory (DHI)
Time frame: 4 years post-implantation up to 5 years post-enrollment
EM1.4: SF6D utility (SF6DU) score
Time frame: 4 years post-implantation up to 5 years post-enrollment
EM2.1: Vestibular Implant Composite Outcome (VICO) score
Time frame: 4 years post-implantation up to 5 years post-enrollment
EM2.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT)
Time frame: 4 years post-implantation up to 5 years post-enrollment
EM2.3: Dizziness Handicap Inventory (DHI)
Time frame: 4 years post-implantation up to 5 years post-enrollment
EM2.4: SF6D utility (SF6DU) score
Time frame: 4 years post-implantation up to 5 years post-enrollment
EM2.5: Dynamic Gait Index (DGI)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 4 years post-implantation up to 5 years post-enrollment
SM1.2: implant-side air-conduction 4-frequency pure tone average detection threshold (AirPTAi)
Time frame: 4 years post-implantation up to 5 years post-enrollment
SM1.3: implant-side consonant-nucleus-consonant word discrimination score (CNCWi)
Time frame: 4 years post-implantation up to 5 years post-enrollment
SM1.4: sound-field Arizona Biology (AzBios)27 sentences-in-noise discrimination score
Time frame: 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
Time frame: 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
Time frame: 4 years post-implantation up to 5 years post-enrollment
SM1.7: implant-side distortion-product otoacoustic emissions
Time frame: 4 years post-implantation up to 5 years post-enrollment
SM1.8: Ear canal acoustic admittance as assessed by implant-side tympanometry
Time frame: 4 years post-implantation up to 5 years post-enrollment
SM1.9: Tinnitus Handicap Inventory (THI)
Time frame: 4 years post-implantation up to 5 years post-enrollment
SM1.10: Autophony Index (AI)
Time frame: 4 years post-implantation up to 5 years post-enrollment
SM1.11: cervical vestibular-evoked myogenic potential (cVEMP) response amplitude
Time frame: 4 years post-implantation up to 5 years post-enrollment
SM1.12: ocular vestibular-evoked myogenic potential (oVEMP) response amplitude
Time frame: 4 years post-implantation up to 5 years post-enrollment
SM1.13: subjective visual vertical (SVV) as assessed using the Bucket Test
Time frame: 4 years post-implantation up to 5 years post-enrollment
SM1.14: scalp thickness at the location of implanted magnets (Tscalp)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 years post-implantation up to 5 years post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 25790951Sun DQ, Lehar M, Dai C, Swarthout L, Lauer AM, Carey JP, Mitchell DE, Cullen KE, Della Santina CC. Histopathologic Changes of the Inner ear in Rhesus Monkeys After Intratympanic Gentamicin Injection and Vestibular Prosthesis Electrode Array Implantation. J Assoc Res Otolaryngol. 2015 Jun;16(3):373-87. doi: 10.1007/s10162-015-0515-y. Epub 2015 Mar 20.
- Background: PubMed 24763518Sun 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.
- Background: PubMed 24147142Mitchell 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.
- Background: PubMed 24013822Dai C, Fridman GY, Chiang B, Rahman MA, Ahn JH, Davidovics NS, Della Santina CC. Directional plasticity rapidly improves 3D vestibulo-ocular reflex alignment in monkeys using a multichannel vestibular prosthesis. J Assoc Res Otolaryngol. 2013 Dec;14(6):863-77. doi: 10.1007/s10162-013-0413-0. Epub 2013 Sep 8.
- Background: PubMed 23949355Ward BK, Agrawal Y, Hoffman HJ, Carey JP, Della Santina CC. Prevalence and impact of bilateral vestibular hypofunction: results from the 2008 US National Health Interview Survey. JAMA Otolaryngol Head Neck Surg. 2013 Aug 1;139(8):803-10. doi: 10.1001/jamaoto.2013.3913.
- Background: PubMed 23649285Valentin NS, Hageman KN, Dai C, Della Santina CC, Fridman GY. Development of a multichannel vestibular prosthesis prototype by modification of a commercially available cochlear implant. IEEE Trans Neural Syst Rehabil Eng. 2013 Sep;21(5):830-9. doi: 10.1109/TNSRE.2013.2259261. Epub 2013 May 1.
- Background: PubMed 23355001Davidovics NS, Rahman MA, Dai C, Ahn J, Fridman GY, Della Santina CC. Multichannel vestibular prosthesis employing modulation of pulse rate and current with alignment precompensation elicits improved VOR performance in monkeys. J Assoc Res Otolaryngol. 2013 Apr;14(2):233-48. doi: 10.1007/s10162-013-0370-7. Epub 2013 Jan 26.
- Background: PubMed 23044664Fridman GY, Della Santina CC. Progress toward development of a multichannel vestibular prosthesis for treatment of bilateral vestibular deficiency. Anat Rec (Hoboken). 2012 Nov;295(11):2010-29. doi: 10.1002/ar.22581. Epub 2012 Oct 8.
- Background: PubMed 22255006Rahman MA, Dai C, Fridman GY, Davidovics NS, Chiang B, Ahn J, Hayden R, Melvin TA, Sun DQ, Hedjoudje A, Della Santina CC. Restoring the 3D vestibulo-ocular reflex via electrical stimulation: the Johns Hopkins multichannel vestibular prosthesis project. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:3142-5. doi: 10.1109/IEMBS.2011.6090857.
- Background: PubMed 21888961Dai C, Fridman GY, Davidovics NS, Chiang B, Ahn JH, Della Santina CC. Restoration of 3D vestibular sensation in rhesus monkeys using a multichannel vestibular prosthesis. Hear Res. 2011 Nov;281(1-2):74-83. doi: 10.1016/j.heares.2011.08.008. Epub 2011 Aug 26.
- Background: PubMed 21374081Dai C, Fridman GY, Chiang B, Davidovics NS, Melvin TA, Cullen KE, Della Santina CC. Cross-axis adaptation improves 3D vestibulo-ocular reflex alignment during chronic stimulation via a head-mounted multichannel vestibular prosthesis. Exp Brain Res. 2011 May;210(3-4):595-606. doi: 10.1007/s00221-011-2591-5. Epub 2011 Mar 4.
- Background: PubMed 21195755Dai C, Fridman GY, Della Santina CC. Effects of vestibular prosthesis electrode implantation and stimulation on hearing in rhesus monkeys. Hear Res. 2011 Jul;277(1-2):204-10. doi: 10.1016/j.heares.2010.12.021. Epub 2010 Dec 31.
- Individual participant dataSharing planned: Yes. Publication of de-identified data via peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John P Carey, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labyrinth Devices MVI™ Multichannel Vestibular Implant System in people with Bilateral Vestibular Hypofunction and Bilateral Vestibular Deficiency, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Lane (410-502-8047, vestibularimplant@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06500975, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.