Vestibular Implant for Bilateral Vestibulopathy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device, the Labyrinth Devices MVI™ Multichannel Vestibular Implant, designed to aid individuals with chronic imbalance and unsteady vision caused by inner ear problems. The researchers aim to determine if the device can enhance balance and vision by using electrical signals to stimulate the inner ear. Candidates may include those with persistent balance issues unresponsive to other treatments who can still hear well enough to communicate in one ear. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to innovative solutions for balance and vision issues.
Will I have to stop taking my current medications?
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 not be eligible to participate.
What prior data suggests that this vestibular implant is safe for humans?
Research shows that the Labyrinth Devices MVI™ Multichannel Vestibular Implant has been tested in people and has demonstrated promising safety results. Earlier studies found that some patients with the implant experienced improved balance and more stable vision.
Researchers have recorded side effects to monitor safety, but these are usually expected in early studies. Participants have generally tolerated the device well, with manageable side effects. It is important to note that this implant is still under study for its full potential, but early results suggest it might be a safe option for those with balance issues.12345Why are researchers excited about this trial?
The Labyrinth Devices MVI™ Multichannel Vestibular Implant is unique because it offers a new way to manage bilateral vestibulopathy by directly stimulating the vestibular system. Unlike standard treatments such as vestibular rehabilitation therapy or medications that mainly focus on symptom relief, this implant targets the root cause by compensating for lost vestibular function. Researchers are excited about its potential to improve balance and spatial orientation more effectively than current options, providing a more direct and potentially transformative solution for those affected by this condition.
What evidence suggests that the Labyrinth Devices MVI™ Multichannel Vestibular Implant is effective for bilateral vestibulopathy?
Research has shown that the Labyrinth Devices MVI™ Multichannel Vestibular Implant, which participants in this trial will receive, might help people with balance issues caused by inner ear problems. Studies indicate that using electrical signals on the balance nerve can restore some balance reflexes in individuals with damage to balance-related cells. One study found that even 23 years after balance issues began, this implant could still activate important balance responses. This suggests it might improve stability and maintain steady vision. Although this is an early study with limited data, the initial results are promising for those with long-term balance problems.12467
Who Is on the Research Team?
John P Carey MD (Independent/Nonconflicted IRB Protocol PI)
Principal Investigator
Johns Hopkins School of Medicine
Are You a Good Fit for This Trial?
Adults aged 22-90 with severe balance and vision issues due to inner ear dysfunction, who haven't improved with rehab. They must be able to travel for tests and commit to a vestibular exercise regimen. Excluded are those with certain medical conditions, recent eye injuries, severe kidney problems, nursing women, or anyone unable to follow the study's procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Activation
Participants undergo implantation, activation, and deactivation of the Labyrinth Devices MVI™ Multichannel Vestibular Implant System
Post-operative Monitoring
Participants are monitored for safety, tolerability, and efficacy of the implant over a period of up to 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Labyrinth Devices MVI™ Multichannel Vestibular Implant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Labyrinth Devices, LLC
Collaborator