Patients who suffer from neuromuscular diseases such as locked-in syndrome or muscular dystrophy have difficulty communicating through speech, which negatively impacts their quality of life. The most common speech aids for these disorders can track a patient’s eye movement to spell and read out words, but these signals and spellers are often slow and inconsistent. Researchers have long explored how they can use neural prostheses to translate brain signals into speech yet these efforts have faced numerous technological limitations.
Electrical and computer engineering chair, Florian Solzbacher will support a team of Duke University researchers on a project to develop and optimize wireless electrode arrays for the use of speech neural prostheses. The team’s goal is to develop a speech prosthetic that allows a patient to imagine speaking, and a computer to produce a voice for them. Previous teams have created similar devices with just 128 individually wired electrodes, but the new project intends to develop an array with thousands of electrodes that are fully implanted and wireless. This would allow for higher performance decoding and support natural language speech that is both faster and more efficient.
Jonathan Viventi, assistant professor in Duke University’s Department of Biomedical Engineering and the project’s principal investigator, was awarded a $3.8 million R01 grant by the National Institute of Health that will fund the team for five years. According to Viventi, the arrays will be implanted on targeted areas of the brain, then wirelessly communicate with an external component on the patient’s head, like a cochlear implant. The external component would then send the data to a computer where it would translate the signals into speech. The external component would also be rechargeable and wireless.
Solzbacher’s lab will work with Salt Lake City-based neuroscience company Blackrock Neurotech, of which Solzbacher is cofounder and chairman, throughout the study to ensure that the technology developed can be FDA-approved and commercialized at the end of the project. Solzbacher and his team will conduct extensive benchtop and lifetime testing of the device to ensure it is functional and in compliance with regulatory requirements. His team will identify failure modes, demonstrate the safety and reliability of the device, and generate the necessary documentation for the project, including defining test protocols, processes and more. Their contribution will provide assurance that once the device reaches the marketplace, it will be safe and effective when placed in a human subject.
Blackrock Neurotech will contribute its expertise to the commercialization of the device. The company offers a wide variety of electrode, electronics, implant systems and software solutions for implantable devices and neural interfaces as part of their technology platform. Blackrock is the leader in brain-computer interface technology and is the first to enable a fully locked-in amyotrophic lateral sclerosis (ALS) patient to communicate again using signals directly controlled by their mind. They are the only company with an (FDA cleared) implantable penetrating high channel electrode array that has demonstrated reliable function in several dozen human subjects in sub-chronic and chronic settings with lifetimes exceeding 7 years in vivo in FDA approved IDE studies. The device typically has 100 electrodes and is often used in configurations with multiple electrode assemblies, creating hundreds of channels of access to individual single unit action potential signals that can be used to restore motor and sensory function in people who have lost those due to injury or disease.
“We are grateful for the partnership with Dr. Viventi and Duke University in our efforts to develop devices that help people who have lost function and so urgently need new solutions,” said Solzbacher. “Further, this new technology platform has the potential to revolutionize how smart implants are designed, manufactured and tested. It fits perfectly into Blackrock’s strategic technology portfolio, which we are building to increase options for future neural interface products that leapfrog existing technologies.”