Long Term Outcomes After Vestibular Implantation

NCT ID: NCT06500975

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2029-12-31

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) .

Conditions

Bilateral Vestibular Hypofunction; Bilateral Vestibular Deficiency; Bilateral Vestibulopathy; Gentamicin Ototoxicity; Aminoglycoside Toxicity; Vestibular Diseases; Sensation Disorders; Labyrinth Diseases; Other Disorders of Vestibular Function

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vestibular Implant

Up to 32 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System (MVI)

Group Type: EXPERIMENTAL

Labyrinth Devices MVI™ Multichannel Vestibular Implant System

Intervention Type: DEVICE

Continuously motion-modulated stimulation delivered by a vestibular implant already implanted under a prior study protocol (Labyrinth Devices MVI™ Multichannel Vestibular Implant System)

Interventions

Labyrinth Devices MVI™ Multichannel Vestibular Implant System

Continuously motion-modulated stimulation delivered by a vestibular implant already implanted under a prior study protocol (Labyrinth Devices MVI™ Multichannel Vestibular Implant System)

Intervention Type: DEVICE

Other Intervention Names

Motion-modulated stimulation delivered by a vestibular implant already implanted under a prior study protocol

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Labyrinth Devices, LLC

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John P Carey, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kelly Lane

Role: CONTACT

vestibularimplant@jhmi.edu

410-502-8047

Charles C Della Santina, MDPhD

Role: CONTACT

cds@jhmi.edu

410-502-8047

Facility Contacts

Lauren N Trainer, BS

Role: primary

vestibularimplant@jhmi.edu

410-502-5129

Charles C Della Santina, MDPhD

Role: backup

vestibularimplant@jhmi.edu

410-502-8047

References

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.

Reference Type: BACKGROUND

PMID: 25790951 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24763518 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24147142 (View on PubMed)

Dai 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.

Reference Type: BACKGROUND

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Ward 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.

Reference Type: BACKGROUND

PMID: 23949355 (View on PubMed)

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Davidovics 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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 22255006 (View on PubMed)

Dai 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.

Reference Type: BACKGROUND

PMID: 21888961 (View on PubMed)

Dai 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.

Reference Type: BACKGROUND

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Dai 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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

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Related Links

http://www.jhu.edu/vnel

Trial-related news updates and links to application

Other Identifiers

IRB00434328

Identifier Type: -

Identifier Source: org_study_id