Trials / Recruiting

RecruitingNCT05674786

Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 8 (estimated)

Sponsor: Johns Hopkins University · Academic / Other
Sex: All
Age: 22 Years – 90 Years
Healthy volunteers: Not accepted

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).

Conditions

Interventions

Type	Name	Description
DEVICE	Labyrinth Devices MVI™ Multichannel Vestibular Implant System	Unilateral implantation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System receiver/stimulator including insertion of electrode arrays in the semicircular canal ampullae of the inner ear, followed by motion-modulated prosthetic electrical stimulation.

Timeline

Start date: 2023-02-28
Primary completion: 2026-12-31
Completion: 2027-03-31
First posted: 2023-01-06
Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT05674786. Inclusion in this directory is not an endorsement.