Vestibular Implant for Bilateral Vestibulopathy

Overseen By Charles C Della Santina MD, PhD, (Lead Surgeon)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Alcohol, others

Disqualifiers: Blindness, Acoustic neuroma, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

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.

Is the vestibular implant safe for humans?

Research on the vestibular implant, including the Labyrinth Devices MVI™ Multichannel Vestibular Implant, shows it has been tested in humans with different conditions, and no major safety concerns have been reported in these studies. ^{1 2 3 4 5}

How is the Labyrinth Devices MVI™ Multichannel Vestibular Implant treatment different from other treatments for bilateral vestibulopathy?

The Labyrinth Devices MVI™ Multichannel Vestibular Implant 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 physical therapy, as it directly targets the vestibular system to improve balance and stability. ^{6 7 8 9 10}

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 adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to loss of vestibular hair cell function. Preclinical studies have demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular prosthesis can partially restore vestibular reflexes that maintain steady posture and vision. This pilot clinical feasibility study of a multichannel vestibular implant system will evaluate this approach in up to ten human subjects with bilateral vestibular deficiency due to gentamicin ototoxicity or other causes of inner ear dysfunction.

Research Team

John P Carey MD (Independent/Nonconflicted IRB Protocol PI)

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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

My hearing in both ears meets the study's requirements.

Motivated to travel to the study center, undergo testing and examinations, and participate actively in a vestibular rehabilitation exercise regimen

I am between 22 and 90 years old with a balance disorder not improved by therapy.

Exclusion Criteria

I have severe bone, nerve, or other non-ear related health issues.

I have fainted or had a strong dizzy spell from eye procedures before.

I have no health issues preventing surgery, anesthesia, or study participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Activation

Participants undergo implantation, activation, and deactivation of the Labyrinth Devices MVI™ Multichannel Vestibular Implant System

24 weeks

Visits at weeks 0, 6, 8, and 10

Post-operative Monitoring

Participants are monitored for safety, tolerability, and efficacy of the implant over a period of up to 1 year

1 year

Visits at weeks 0, and 3 through 10

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Labyrinth Devices MVI™ Multichannel Vestibular Implant

Trial Overview The trial is testing a device called the Labyrinth Devices MVI™ Multichannel Vestibular Implant in up to ten people. It aims to restore balance and stable vision in patients with bilateral vestibular deficiency by electrically stimulating the vestibular nerve.

Participant Groups

Group I: vestibular implant Experimental Treatment 1 Intervention

Up to 30 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+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Labyrinth Devices, LLC

Collaborator

Trials

4

Recruited

90+

Findings from Research

In a study involving three subjects with unilateral Meniere's disease, simultaneous labyrinthectomy and cochlear implantation led to significant improvements in sound localization and speech perception over a 6-month period, with sound localization error decreasing from 63 degrees to 22 degrees with the cochlear implant activated.

Participants also experienced a remarkable reduction in tinnitus severity, with the Tinnitus Handicap Inventory score improving from an average of 42 preoperatively to 0 at 6 months, alongside overall enhancements in quality of life measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous labyrinthectomy and cochlear implantation in unilateral meniere's disease. Perkins, E., Rooth, M., Dillon, M., et al.[2022]

The study involved three patients with severe-profound deafness and bilateral vestibular loss who received vestibular-cochlear implants, revealing that the cause of vestibular loss significantly affects the outcomes of the implant.

Two of the subjects demonstrated robust vestibular responses with high eye movement velocities from electrical stimulation, suggesting that the sensitivity of vestibular afferents varies based on the underlying condition, which may influence the effectiveness of vestibular implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results From a Second-Generation Vestibular Implant in Human Subjects: Diagnosis May Impact Electrical Sensitivity of Vestibular Afferents. Rubinstein, JT., Ling, L., Nowack, A., et al.[2021]

A vestibular implant successfully elicited artificial sensations of head movement in a 55-year-old man who had experienced 23 years of bilateral vestibular hypofunction, demonstrating the potential for long-term recovery of vestibular function.

The electrically evoked vestibulo-ocular reflexes (eeVOR) showed alignment and magnitude similar to those seen in patients implanted less than 10 years after onset, indicating that prosthetic stimulation can effectively restore vestibular responses even after a prolonged period of dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular Implantation Can Work Even After More Than 20 Years of Bilateral Vestibular Hypofunction. Schoo, DP., Ayiotis, AI., Fernandez Brillet, C., et al.[2023]

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 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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Characteristics of vestibular-evoked myogenic potentials in children with vestibular malformation and severe sensorineural hearing loss. [2023]

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

Simultaneous labyrinthectomy and cochlear implantation in unilateral meniere's disease. [2022]

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

Results From a Second-Generation Vestibular Implant in Human Subjects: Diagnosis May Impact Electrical Sensitivity of Vestibular Afferents. [2021]

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

Vestibular Implantation Can Work Even After More Than 20 Years of Bilateral Vestibular Hypofunction. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The vestibular implant: quo vadis? [2022]

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

10. Switzerland pubmed.ncbi.nlm.nih.gov

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