Vestibular Implant for Bilateral Vestibulopathy

Overseen By Kelly Lane (Study Coordinator)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Alcohol, others

Disqualifiers: Blindness, Pregnancy, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

8 Participants Needed

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 System (also known as the Vestibular Implant), designed to help people with chronic balance issues due to bilateral vestibular hypofunction. The researchers aim to determine if this implant can improve balance, posture, and vision stability in everyday life. Individuals who have experienced balance problems for more than a year, despite trying other treatments, might be suitable for the trial. The study seeks participants with a specific hearing profile, where hearing in one ear is poorer or equal to the other. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for those with balance disorders.

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.

What prior data suggests that this vestibular implant is safe for individuals with bilateral vestibular hypofunction?

Research shows that the Labyrinth Devices MVI™ Multichannel Vestibular Implant System could assist individuals with balance problems due to issues in both inner ears. In earlier studies, researchers tested this implant on participants and found it may improve balance reflexes. These reflexes are crucial for maintaining steady posture and clear vision.

So far, the implant has generally been well-tolerated. Recipients have not reported any serious side effects, though the data comes from a small group of participants. Ongoing research aims to confirm these results and ensure the implant's safety for a broader population. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for bilateral vestibulopathy focus on managing symptoms through physical therapy and medications to reduce dizziness. However, the Labyrinth Devices MVI™ Multichannel Vestibular Implant System is unique because it directly targets the malfunctioning vestibular system by actively restoring its function. This implant provides continuous, precise stimulation to the vestibular nerves, which could dramatically improve balance and stability. Researchers are excited about this treatment because it offers a potential breakthrough in restoring natural vestibular function, potentially improving quality of life for patients in a way that current therapies cannot.

What evidence suggests that the Labyrinth Devices MVI™ Multichannel Vestibular Implant System is effective for bilateral vestibulopathy?

Research has shown that the Labyrinth Devices MVI™ Multichannel Vestibular Implant System, which participants in this trial will receive, can assist people with bilateral vestibular hypofunction, a condition causing ongoing balance problems and blurry vision. Studies have found that this implant can send electrical signals to the vestibular nerve, helping restore some reflexes needed for steady posture and clear vision. Users of this implant have reported better balance and an improved quality of life. Even those with long-standing balance issues have experienced positive results, suggesting the treatment's effectiveness. Overall, these findings indicate that the implant may be a promising option for those dealing with this condition. ^{1 2 4 6 7}

Who Is on the Research Team?

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.

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

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?

Group I: vestibular implant Experimental Treatment 1 Intervention

Up to 8 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System

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:

• Bilateral vestibular hypofunction (BVH)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Vestibular Stimulation in Humans: A Narrative Review. Sluydts, M., Curthoys, I., Vanspauwen, R., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of a vestibular implant for the rehabilitation of bilateral deafness]. Guyot, JP., Sigrist, A., Kos, I.[2009]

A systematic review of 10 studies involving 18 patients with vestibular implants indicates that these devices can effectively restore vestibular function, particularly the vestibulo-ocular reflex, which is crucial for balance and spatial orientation.

All studies included in the review showed a low risk of bias, supporting the reliability of the findings and highlighting the potential of vestibular implants to improve the quality of life for individuals with bilateral vestibular loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular implant: does it really work? A systematic review. Azevedo, YJ., Ledesma, ALL., Pereira, LV., et al.[2022]

The development of vestibular implants (VIs) for humans appears feasible in the near future, as studies indicate that electrical stimulation of canal nerves can induce nystagmus, which aligns with the stimulated canal's orientation.

The effectiveness of VIs may depend on individual factors such as the specific vestibular pathology and the person's ability to adapt to the stimulation, suggesting a need for personalized approaches in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The vestibular implant: quo vadis? van de Berg, R., Guinand, N., Stokroos, RJ., et al.[2022]

A study involving 13 participants with unilateral vestibular deficits showed that computerized dynamic posturography-assisted vestibular retraining led to significant improvements in self-reported disability, particularly for those with moderate to severe initial disability.

After 12 sessions of retraining, 62% of participants exceeded the minimum clinically important difference in their Dizziness Handicap Inventory scores, indicating meaningful improvements in their quality of life and balance confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Disability After Computerized Posturographic Vestibular Retraining for Stable Unilateral Vestibular Deficit. David, EA., Shahnaz, N.[2023]

The implantable vestibular stimulation system can independently stimulate the semicircular canals in the inner ear, potentially restoring the three-dimensional sensation of head movements.

The system effectively minimizes interference between stimulation channels, allowing for simultaneous current delivery with minimal crosstalk, which is crucial for accurate vestibular function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A vestibular prosthesis with highly-isolated parallel multichannel stimulation. Jiang, D., Cirmirakis, D., Demosthenous, A.[2015]

The new multichannel vestibular prosthesis (MVP) is designed to restore vestibular function in individuals with bilateral loss of vestibular sensation, potentially alleviating symptoms like chronic disequilibrium and postural instability.

Improvements in the MVP include a smaller size, lower power consumption, and enhanced electrode design for better nerve coupling, which were validated through both bench-top tests and in vivo experiments with a rhesus macaque monkey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and performance of a multichannel vestibular prosthesis that restores semicircular canal sensation in rhesus monkey. Chiang, B., Fridman, GY., Dai, C., et al.[2021]

In a study involving four patients with bilateral vestibulopathy, the interaction between residual 'natural' vestibular input and 'artificial' vestibular implant input was found to significantly affect eye movement responses, indicating a complex integration process in the central vestibular system.

The results showed that 'artificial' vestibular implant input could influence and counteract the response to residual 'natural' input, suggesting the potential for developing a 'vestibular pacemaker' to improve balance and reduce vertigo in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Vestibular Implant Input Interacts with Residual Natural Function. van de Berg, R., Guinand, N., Ranieri, M., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral vestibulopathy patients' perspectives on vestibular implant treatment: a qualitative study. van Stiphout, L., Lucieer, F., Guinand, N., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02725463

Multichannel Vestibular Implant Early Feasibility Study This pilot clinical feasibility study of a multichannel vestibular implant system will evaluate this approach in up to ten human subjects with bilateral ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06500975

Long Term Outcomes After Vestibular Implantation This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9851668/

Vestibular Implantation Can Work Even After >20 Years of ... Results: Vestibular implant stimulation can drive stimulus-aligned eeVOR and elicit a vestibular percept 23 years after the onset of bilateral vestibulopathy.

4. clinicaltrial.be clinicaltrial.be/en/details/73334?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Multichannel Vestibular Implant Early Feasibility Study -... The system used in this study is the (MVI)™ Multichannel Vestibular Implant System produced by Labyrinth Devices, LLC.

5. ctv.veeva.com ctv.veeva.com/study/long-term-outcomes-after-vestibular-implantation

Long Term Outcomes After Vestibular Implantation There is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6948863/

Continuous vestibular implant stimulation partially restores ... We report binocular 3D VOR responses of 4 human subjects with ototoxic bilateral vestibular loss unilaterally implanted with a Labyrinth Devices Multichannel ...

7. link.springer.com link.springer.com/article/10.1007/s40136-024-00502-8

Vestibular Implantation | Current Otorhinolaryngology ... Published clinical trial results suggest vestibular implants can electrically drive vestibular mediated reflexes, including the vestibulo-ocular ...