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.
What safety data exists for the vestibular implant treatment?The available research indicates that the vestibular implant, including the Labyrinth Devices MVI Multichannel Vestibular Implant System, is still in the experimental stage. Studies have been conducted to assess its feasibility and performance, such as experiments in human subjects in Geneva and in vivo tests with rhesus monkeys. These studies suggest promising results, but comprehensive safety data is not yet established due to the ongoing nature of the research.12369
Is the Labyrinth Devices MVI Multichannel Vestibular Implant System a promising treatment for people with balance problems due to bilateral vestibulopathy?Yes, the Labyrinth Devices MVI Multichannel Vestibular Implant System is a promising treatment. It aims to restore balance by using electrical signals to help the brain sense head movements, similar to how a cochlear implant helps with hearing. Research shows it can improve balance and stability, making it a hopeful option for those with balance issues.12456
What data supports the idea that Vestibular Implant for Bilateral Vestibulopathy is an effective treatment?The available research shows that the Vestibular Implant is being explored as a promising treatment for people with bilateral vestibulopathy, a condition where the balance system in both ears is damaged. Traditional treatments like medication and surgery often don't work well for these patients. The research highlights that the Vestibular Implant, along with other methods like cochlear implants and galvanic stimulation, shows potential in restoring balance function. However, it's still in the experimental stage, and more studies are needed to determine its effectiveness compared to other treatments.15678
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. However, if your medications interfere with vestibular compensation, you may be excluded from the trial.
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.
My balance issues are not due to inner ear damage.
Treatment Details
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.
1Treatment groups
Experimental Treatment
Group I: vestibular implantExperimental Treatment1 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 nearbySelect from list below to view details:
Johns Hopkins School of MedicineBaltimore, MD
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
Labyrinth Devices, LLCCollaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
References
[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.
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.
The vestibular implant: quo vadis? [2022]To assess the progress of the development of the vestibular implant (VI) and its feasibility short-term.
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.
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."
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.
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.
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.
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.