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Device

Vestibular Implant for Bilateral Vestibulopathy

N/A

Recruiting

Led By John P Carey, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Adults age 22-90 years diagnosed with ototoxic, idiopathic or non-ototoxic/non-central bilateral vestibular hypofunction inadequately responsive to vestibular rehabilitation for greater than 1 year as determined by pre-inclusion history, vestibular testing and clinical examination conducted by a board-certified neurotologist, neurologist or other physician skilled in diagnosis of vestibular disorders

Must not have

Diagnosis of specific medical conditions including acoustic neuroma/vestibular schwannoma, chronic middle ear disease, cholesteatoma, or central nervous system causes of vestibulo-ocular reflex dysfunction

Vestibular dysfunction known to be caused by specific reasons other than labyrinthine injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from 3 weeks post-implantation to 6 months post-implantation

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a device to help those w/ non-ototoxic vestibular hypofunction to improve posture & vision, reduce disability & improve quality of life.

Who is the study for?

Adults aged 22-90 with severe bilateral vestibular hypofunction, which causes chronic imbalance and vision issues, are eligible. They must have specific imaging results showing no central nervous system causes for their condition, be motivated for rehabilitation exercises, not swim or operate dangerous machinery during the study, and agree to recommended vaccinations. Pregnant or nursing women and those with certain medical conditions like acoustic neuroma are excluded.

What is being tested?

The trial is testing the Labyrinth Devices MVI™ Multichannel Vestibular Implant System on individuals who haven't responded well to other treatments for balance disorders caused by inner ear problems. It's a single-arm open-label study aiming to improve stability and quality of life in up to fifteen adults.

What are the potential side effects?

Potential side effects may include loss of residual hearing in the implanted ear, altered sensation around the implant site, device failure requiring replacement or removal, dizziness during initial activation or adjustment periods, and possible risk of meningitis despite vaccination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My brain MRI showed no tumors or causes for hearing and balance issues.

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I am between 22-90 years old with a balance disorder not improved by therapy for over a year.

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My CT scans show normal ear structures suitable for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a specific ear or brain condition affecting my balance or hearing.

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My balance issues are not due to inner ear damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from 3 weeks post-implantation to 6 months post-implantation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from 3 weeks post-implantation to 6 months post-implantation

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from 3 weeks post-implantation to 6 months post-implantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PM1.1: Dynamic Gait Index (DGI) during motion-modulated implant stimulation at 6 months post-implantation, relative to pre-operative baseline, aggregated across all implant users.

PM1.2: Gain (VHITG) of the vestibulo-ocular reflex, as measured using the video head impulse test averaged for the three implanted semicircular canals, relative to pre-operative baseline, aggregated across all implant users.

Secondary study objectives

EM1.1: Vestibular Implant Composite Outcome (VICO) score at 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.

EM1.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT) score 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.

EM1.3: Dizziness Handicap Inventory (DHI) score at 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.

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Other study objectives

XM1.1 (A,B,C): Change in vestibulo-ocular reflex (VOR) latency (msec) during video head impulse testing (VHIT) at 6 months post-implantation, relative to preoperative baseline values

XM1.2 (A,B,C): Change in saccade latency (msec) during video head impulse testing (VHIT) at 6 months post-implantation, relative to preoperative baseline values

XM10.1 (A,B,C): Change in time to complete the Trail Making Test Part B (TMT)

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