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.

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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.

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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.

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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

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins School of Medicine Baltimore, MD

Who Is Running the Clinical Trial?

Johns Hopkins University Lead Sponsor

Labyrinth Devices, LLC Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD) Collaborator

References

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

Electrical Vestibular Stimulation in Humans: A Narrative Review. [2020] In patients with bilateral vestibulopathy, the regular treatment options, such as medication, surgery, and/or vestibular rehabilitation, do not always suffice. Therefore, the focus in this field of vestibular research shifted to electrical vestibular stimulation (EVS) and the development of a system capable of artificially restoring the vestibular function. Key Message: Currently, three approaches are being investigated: vestibular co-stimulation with a cochlear implant (CI), EVS with a vestibular implant (VI), and galvanic vestibular stimulation (GVS). All three applications show promising results but due to conceptual differences and the experimental state, a consensus on which application is the most ideal for which type of patient is still missing.

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

Bilateral vestibulopathy patients' perspectives on vestibular implant treatment: a qualitative study. [2022] The aim of this study was to explore expectations of patients with bilateral vestibulopathy regarding vestibular implant treatment. This could advance the definition of recommendations for future core outcome sets of vestibular implantation and help to determine on which characteristics of bilateral vestibulopathy future vestibular implant research should focus.

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

[Development of a vestibular implant for the rehabilitation of bilateral deafness]. [2009] The development of a vestibular implant for the rehabilitation of bilateral vestibular loss is funded on a concept comparable to that of the cochlear implant used in the rehabilitation of bilateral deafness. This paper carries an overview of the main aspects of such a development and describes the first experiments done in human subjects in Geneva.

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

The Vestibular Implant Input Interacts with Residual Natural Function. [2022] Patients with bilateral vestibulopathy (BV) can still have residual "natural" function. This might interact with "artificial" vestibular implant input (VI-input). When fluctuating, it could lead to vertigo attacks. Main objective was to investigate how "artificial" VI-input is integrated with residual "natural" input by the central vestibular system. This, to explore (1) whether misalignment in the response of "artificial" VI-input is sufficiently counteracted by well-aligned residual "natural" input and (2) whether "artificial" VI-input is able to influence and counteract the response to residual "natural" input, to show feasibility of a "vestibular pacemaker."

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

Vestibular implant: does it really work? A systematic review. [2022] People with vestibular loss present a deficit in the vestibular system, which is primarily responsible for promoting postural control, gaze stabilization, and spatial orientation while the head moves. There is no effective treatment for a bilateral loss of vestibular function. Recently, a vestibular implant was developed for people with bilateral loss of vestibular function to improve this function and, consequently, the quality of life of these patients.

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

The vestibular implant: quo vadis? [2022] To assess the progress of the development of the vestibular implant (VI) and its feasibility short-term.

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] In normal individuals, the vestibular labyrinths sense head movement and mediate reflexes that maintain stable gaze and posture. Bilateral loss of vestibular sensation causes chronic disequilibrium, oscillopsia, and postural instability. We describe a new multichannel vestibular prosthesis (MVP) intended to restore modulation of vestibular nerve activity with head rotation. The device comprises motion sensors to measure rotation and gravitoinertial acceleration, a microcontroller to calculate pulse timing, and stimulator units that deliver constant-current pulses to microelectrodes implanted in the labyrinth. This new MVP incorporates many improvements over previous prototypes, including a 50% decrease in implant size, a 50% decrease in power consumption, a new microelectrode array design meant to simplify implantation and reliably achieve selective nerve-electrode coupling, multiple current sources conferring ability to simultaneously stimulate on multiple electrodes, and circuitry for in vivo measurement of electrode impedances. We demonstrate the performance of this device through in vitro bench-top characterization and in vivo physiological experiments with a rhesus macaque monkey.

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

Patient-Reported Disability After Computerized Posturographic Vestibular Retraining for Stable Unilateral Vestibular Deficit. [2023] Individuals with persistent unilateral vestibular deficits experience loss of quality of life and increased risk of falling, and they have few well-supported options for effective treatment.

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

A vestibular prosthesis with highly-isolated parallel multichannel stimulation. [2015] This paper presents an implantable vestibular stimulation system capable of providing high flexibility independent parallel stimulation to the semicircular canals in the inner ear for restoring three-dimensional sensation of head movements. To minimize channel interaction during parallel stimulation, the system is implemented with a power isolation method for crosstalk reduction. Experimental results demonstrate that, with this method, electrodes for different stimulation channels located in close proximity ( mm) can deliver current pulses simultaneously with minimum inter-channel crosstalk. The design features a memory-based scheme that manages stimulation to the three canals in parallel. A vestibular evoked potential (VEP) recording unit is included for closed-loop adaptive stimulation control. The main components of the prototype vestibular prosthesis are three ASICs, all implemented in a 0.6- μm high-voltage CMOS technology. The measured performance was verified using vestibular electrodes in vitro.