Vestibular Implant for Bilateral Vestibulopathy

Recruiting in Palo Alto (17 mi)

Overseen by John Carey, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Must not be taking: Alcohol, others

Disqualifiers: Blindness, Pregnancy, Heart failure, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 3 4 7 9}

Research Team

John Carey, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Labyrinth Devices MVI™ Multichannel Vestibular Implant System (Device)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Labyrinth Devices, LLC

Collaborator

Trials

4

Recruited

90+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Joshua M. Levy

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Medical Officer

MD, MPH, MS

Debara L. Tucci

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Executive Officer since 2019

MD, MS, MBA

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Electrical Vestibular Stimulation in Humans: A Narrative Review. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Bilateral vestibulopathy patients' perspectives on vestibular implant treatment: a qualitative study. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Development of a vestibular implant for the rehabilitation of bilateral deafness]. [2009]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Vestibular Implant Input Interacts with Residual Natural Function. [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

Vestibular implant: does it really work? A systematic review. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The vestibular implant: quo vadis? [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Design and performance of a multichannel vestibular prosthesis that restores semicircular canal sensation in rhesus monkey. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Disability After Computerized Posturographic Vestibular Retraining for Stable Unilateral Vestibular Deficit. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A vestibular prosthesis with highly-isolated parallel multichannel stimulation. [2015]