8 Participants Needed

Vestibular Implant for Bilateral Vestibulopathy

CL
CC
KL
Overseen ByKelly Lane (Study Coordinator)
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using medications, drugs, or alcohol that interfere with vestibular compensation, you may be excluded from participating.

Is the vestibular implant safe for humans?

The vestibular implant, which aims to restore balance function, has been tested in humans and shows promising results, but it is still in the experimental stage, and comprehensive safety data is not yet available.12345

How is the Vestibular Implant treatment different from other treatments for bilateral vestibulopathy?

The Vestibular Implant treatment is unique because it uses a multichannel system to restore vestibular function by electrically stimulating the vestibular nerve, similar to how a cochlear implant restores hearing. This approach is different from traditional treatments like medication or rehabilitation, as it directly targets the vestibular system to improve balance and stability.13467

What data supports the effectiveness of the treatment Vestibular Implant for Bilateral Vestibulopathy?

Research shows that electrical vestibular stimulation, including the use of vestibular implants, is promising for restoring balance and spatial orientation in patients with bilateral vestibulopathy. Although still experimental, these implants are being developed similarly to cochlear implants, which have successfully restored hearing in people with deafness.13689

Who Is on the Research Team?

JP

John Carey, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My brain MRI showed no tumors or causes for hearing and balance issues.
I am between 22-90 years old with a balance disorder not improved by therapy for over a year.
My CT scans show normal ear structures suitable for surgery.
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Exclusion Criteria

I have been diagnosed with a specific ear or brain condition affecting my balance or hearing.
Any medical condition, judged by the investigator team, that is likely to interfere with a study candidate's participation in the study or likely to cause serious adverse events during the study
Various medical conditions and history that may pose risks or interfere with protocol compliance
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Participants undergo unilateral surgical placement of a vestibular implant

Single procedure
1 visit (in-person)

Activation and Initial Treatment

Activation of the vestibular implant and initiation of continuous motion-modulated electrical stimulation

6 months
Regular follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Labyrinth Devices MVI™ Multichannel Vestibular Implant System
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: vestibular implantExperimental Treatment1 Intervention

Labyrinth Devices MVI™ Multichannel Vestibular Implant System is already approved in United States for the following indications:

🇺🇸
Approved in United States as Labyrinth Devices MVI Multichannel Vestibular Implant System for:

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Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Labyrinth Devices, LLC

Collaborator

Trials
4
Recruited
90+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Published Research Related to This Trial

Electrical vestibular stimulation (EVS) is being explored as a treatment for bilateral vestibulopathy, with three promising approaches: vestibular co-stimulation with cochlear implants, vestibular implants, and galvanic vestibular stimulation.
While all three methods have shown effectiveness in stimulating vestibular function, there is currently no consensus on which approach is best suited for specific patient types, indicating a need for further research to determine their applicability and efficiency.
Electrical Vestibular Stimulation in Humans: A Narrative Review.Sluydts, M., Curthoys, I., Vanspauwen, R., et al.[2020]
Patients with bilateral vestibulopathy have clear expectations for vestibular implant treatment, focusing on reducing symptoms, improving daily functions, and enhancing overall quality of life, as identified through semi-structured interviews with 50 patients.
The study highlights that even small improvements in symptoms, such as walking straight and reducing oscillopsia, are valued by patients, providing important insights for future research on vestibular implants.
Bilateral vestibulopathy patients' perspectives on vestibular implant treatment: a qualitative study.van Stiphout, L., Lucieer, F., Guinand, N., et al.[2022]
A vestibular implant is being developed to help people with bilateral vestibular loss, similar to how cochlear implants assist those with bilateral deafness.
Initial experiments with human subjects in Geneva have begun, marking an important step in the rehabilitation of balance disorders caused by vestibular loss.
[Development of a vestibular implant for the rehabilitation of bilateral deafness].Guyot, JP., Sigrist, A., Kos, I.[2009]

Citations

Electrical Vestibular Stimulation in Humans: A Narrative Review. [2020]
Bilateral vestibulopathy patients' perspectives on vestibular implant treatment: a qualitative study. [2022]
[Development of a vestibular implant for the rehabilitation of bilateral deafness]. [2009]
The Vestibular Implant Input Interacts with Residual Natural Function. [2022]
Vestibular implant: does it really work? A systematic review. [2022]
The vestibular implant: quo vadis? [2022]
Design and performance of a multichannel vestibular prosthesis that restores semicircular canal sensation in rhesus monkey. [2021]
Patient-Reported Disability After Computerized Posturographic Vestibular Retraining for Stable Unilateral Vestibular Deficit. [2023]
A vestibular prosthesis with highly-isolated parallel multichannel stimulation. [2015]
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