What is the mechanism of action of this treatment?

Cochlear implants are a common treatment for severe to profound sensorineural hearing loss. They function by bypassing damaged hair cells in the cochlea and directly stimulating the auditory nerve with electrical signals. This allows the brain to perceive sound, effectively restoring hearing. This mechanism is vital for patients as it enables them to regain auditory input, which is essential for communication and improving their quality of life.

What side effects are associated with this type of intervention?

Common treatments for hearing loss involving electrical stimulation, such as cochlear implants and vestibular implants, can have side effects including device-associated adverse events like warm sensations, numbness, redness, itching, tingling, muscle spasms, and localized pain (e.g., arm, shoulder, neck). Additionally, there is a risk of more severe outcomes such as total hearing loss in the treated ear, as seen with gentamicin treatment in some cases. However, serious adverse events are generally rare.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments directly related to hearing loss using electrical stimulation of the vestibular nerve, such as the Multichannel Vestibular Implant. However, cochlear implants, which restore hearing by electrically stimulating the cochlear nerve, are a widely recognized treatment for individuals who have lost cochlear hair cell function. These implants have been approved by the FDA and are commonly used to improve hearing in patients with severe to profound hearing loss.

What other types of research exist?

Promising novel alternatives to Multichannel Vestibular Implant for hearing loss patients include Transcutaneous Supraorbital Nerve Stimulation and Remote Electrical Neuromodulation. Both methods have demonstrated efficacy in reducing migraine pain intensity and could potentially be adapted for hearing loss treatment. Transcutaneous Supraorbital Nerve Stimulation involves external trigeminal nerve stimulation, while Remote Electrical Neuromodulation uses a device controlled by a smartphone to apply nonpainful electrical skin stimulation.

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Vestibular Implant

Vestibular Implant for Age-Related Hearing Loss

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

Be older than 65 years old

Must not have

Subjects with Child-Pugh class C cirrhosis

A history of cervical spine disease preventing head rotation

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 tests a surgically implanted device that sends electrical signals to the balance nerve in older adults with severe balance issues. The device aims to restore natural balance reflexes by mimicking the functions of the damaged inner ear. The vestibular implant is a hybrid system based on a modified cochlear implant designed to restore balance by delivering motion information to the central nervous system using electrical stimulation.

Who is the study for?

This trial is for older adults aged 65-90 with severe balance and vision issues due to bilateral vestibular hypofunction, who haven't improved after a year of rehab. They must be vaccinated per certain protocols, have specific hearing levels, agree not to swim or use heavy machinery during the study, and be able to travel for tests and exercises.

What is being tested?

The Labyrinth Devices MVI™ Multichannel Vestibular Implant System is being tested in this single-arm open-label study. It aims to restore vestibular reflexes which help maintain steady posture and vision in those suffering from chronic imbalance due to inner ear function loss.

What are the potential side effects?

Potential side effects are not explicitly listed but may include risks associated with surgical implantation such as infection, device malfunction or failure, altered sensation around the implant site, dizziness or discomfort.

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 loss or balance issues.

Exclusion Criteria

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

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My liver disease is severe (Child-Pugh class C).

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I cannot turn my head due to a neck condition.

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I have recently injured my eye's cornea.

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I have a diagnosis affecting my inner ear or balance, possibly due to long-term substance use.

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I have severe heart failure.

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I do not have severe neck, ear, or eye conditions that would prevent me from undergoing certain tests.

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My kidney function is low, with a GFR under 30 ml/min.

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.

+64 more

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)

+36 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: vestibular implantExperimental Treatment1 Intervention

Up to 15 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cochlear implants are a common treatment for severe to profound sensorineural hearing loss. They function by bypassing damaged hair cells in the cochlea and directly stimulating the auditory nerve with electrical signals. This allows the brain to perceive sound, effectively restoring hearing. This mechanism is vital for patients as it enables them to regain auditory input, which is essential for communication and improving their quality of life.

Vestibular effects of electrical stimulation of the cochlea. Monitored in the awake primate.Ionic Direct Current Modulation for Combined Inhibition/Excitation of the Vestibular System.Vestibular animal models: contributions to understanding physiology and disease.