What is this study about?
This research is being done to evaluate the safety and ability of a new implanted device to help people who have lost most or all vestibular sensation (inner ear balance function). The vestibular part of the inner ear senses head tilt and rotation during movements like walking. This information drives reflexes that help maintain balance and help keep your eyes and vision stable while you are moving. People who have lost most vestibular sensation in both ears often suffer imbalance, dizziness, difficulty walking in darkness without falling, and blurred or unsteady vision during head movement. Gentamicin toxicity is one of the most common causes of this problem, but there are other causes, as well. In this study, we are studying eye and head movements in people who have lost inner ear balance function, before and after surgical implantation, activation and deactivation of a new electronic implant designed to measure head movement and to stimulate the vestibular nerve in the inner ear. This device, the Multichannel Vestibular Implant, is like a cochlear implant except that it is designed to sense motion rather than sound and to stimulate a different part of the inner ear.
Use of the Multichannel Vestibular Implant in this research study is investigational. The word “investigational” means that the Multichannel Vestibular Implant is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of the Multichannel Vestibular Implant in this study under an investigational device exemption. This approach differs from standard clinical care for bilateral loss of vestibular sensation in that it involves surgical implantation of an electronic stimulator. This is the first time the Multichannel Vestibular Implant is being used in humans. Versions of it have previously been tested in animals. In this study, we will use the implant in only one ear (the study ear).
Am I eligible?
Participants must be 22 to 90 years old with severe loss of inner ear balance sensation in both ears and good hearing in at least one ear.
You will be unable to participate if your vestibular dysfunction is known to be caused by reasons other than inner ear injury due to ototoxicity, loss of blood flow to the inner ear, trauma, infection, Meniere’s disease, or genetic defects known to act on inner ear hair cells. Also, participants will be excluded if they have cochlear implants, on-going vertigo due to active Meniere's disease, immunodeficiency diseases or other medical conditions expected to prevent safe completion of all study procedures
What is involved?
Participation lasts approximately 14 months, including about 2 months to perform initial tests and schedule surgery. The initial tests are part of the screening period, when participants are thoroughly evaluated for auditory (hearing) and vestibular (balance) function. Those who qualify will receive an operation to have the vestibular implant inserted under the skin behind the ear and into the inner ear in a surgery similar to cochlear implantation. During the first 4 months after surgery, the device will be activated and then deactivated. You will then be evaluated in follow-up appointments every quarter (3 months) until 1 year after implant surgery.
How can I learn more about this study?
1. Contact Study Coordinator Desi Schoo, MD at firstname.lastname@example.org
2. Go to the study's listing on ClinicalTrials.gov here.
What information will I need if I want to apply to participate in the trial?
A list of the questions and information that will be required to determine whether you may be a candidate for this study is here.
How can I apply to participate in the trial?
You can apply to participate in the study by clicking here. That link connects you to a survey where you can answer questions that will help determine if you are a candidate for the study. You'll be asked to supply records for vestibular, hearing and imaging test reports. Applying to join the study is easiest if you already have those documents saved as digital files (like PDF files produced by a scanner), because you can then upload them directly to our secure server at that site. The application website will also give you the option of uploading the files later, or mailing hard copies, or faxing.
Where will the study be done, and who are the investigators?
This study will be performed at the Johns Hopkins Outpatient Center and Johns Hopkins Hospital in Baltimore, Maryland. Although we anticipate that future phases of clinical study will include other sites in the United Sates and abroad, this first trial will be limited to a single site.
Who manufactures the vestibular implant used in this study?
This study will use the MVITM Multichannel Vestibular Implant System developed and manufactured by Labyrinth Devices, LLC in collaboration with MedEl GmbH (which makes the implanted stimulator part of the system). The MVITM system is based on technology developed in the Johns Hopkins Vestibular NeuroEngineering Lab and licensed by Labyrinth Devices from the Johns Hopkins University.
Who are the investigators?
This study will be performed by members of the Johns Hopkins Vestibular NeuroEngineering Laboratory, which is led by Charles C. Della Santina MD PhD. As the founder and CEO of Labyrinth Devices, LLC, Dr. Della Santina holds an equity interest in the company, creating a conflict of interest that is managed by the Johns Hopkins Office of Policy Coordination in accordance with Johns Hopkins University policy. John P. Carey MD, who has no affiliation with Labyrinth Devices, is the non-conflicted principal investigator for the study, which has been approved by the Johns Hopkins School of Medicine Institutional Review Board (protocol NA_00051349).
Has the vestibular implant used in this study been approved by the FDA?
The FDA has approved an investigational device exemption (IDE) permitting use of the Labyrinth Devices MVITM Multichannel Vestibular Implant System in this study. An IDE approval to perform a study is not the same as the premarket approval required before a medical device can be adopted into routine clinical use outside of a strictly supervised clinical trial, so use of the system is currently limited to participants in this study.The FDA has also granted Humanitarian Use Designation (HUD) to the Labyrinth Devices MVITM Multichannel Vestibular Implant System.