University researchers — along with teams at the University of California, San Francisco, Mayo Clinic and Oxford — have come together to establish the OpenMind neural communications consortium, a platform to share and disseminate data, protocols and regulatory requirements associated with implantable neurostimulation devices.
“The OpenMind consortium came together as a group of academics to support each other on the development of those (devices), and also their verification and validation,” said Oxford Professor of Engineering Science and Clinical Neurosciences Tim Denison, one of the four OpenMind principal investigators. The consortium was established with funding from the National Institutes of Health.
While each of the four teams focuses on a different disease — Mayo Clinic studies epilepsy, UCSF studies movement disorders, Brown studies psychiatry and the Oxford team helps with the regulatory aspects of the consortium — they use the same core neurostimulation device and technologies to help treat the symptoms of these diseases.
Some main goals of the consortium are to uphold regulatory requirements to ensure that technologies are compliant with the law, to “maximize the probability that protocols are successful” and to ensure the safety of participants, said Denison, who also spent 15 years at the medical device company Medtronics.
Gregory Worrell, a clinical neurologist at the Mayo Clinic and one of the four OpenMind principal investigators, said that “there’s a great infrastructure in the U.S. for managing how research is done and how new technologies are developed. It’s a very nuanced skill set to know how to navigate that federal regulatory space.”
Individual research groups face an “enormous hurdle” in “creating their own clinical protocols and getting their own investigational device exemptions” from the Food and Drug Administration in order to carry out clinical research, said Brown Assistant Professor of Engineering David Borton, who is one of the four principal investigators. This challenge helped prompt the creation of the consortium.
These efforts require “huge clinical translational research teams that understand the complexities of not only the clinical trials or studies but also the devices themselves,” he added.
Through the consortium, teams can share the “expertise” that they’ve developed through their experience in the field with other researchers worldwide, Borton said.
The “public-private element” of OpenMind makes it “unique,” Denison added, as it brings together individuals from industry and academia to evaluate these devices and “work as a community to establish best practices.”
The devices that the consortium focuses on are being used to help treat symptoms of neurological diseases, such as Parkinson’s disease and epilepsy, as well as neuropsychiatric illnesses, such as obsessive compulsive disorder and treatment resistant depression, Borton said.
Although “parts of the technology are specific to the disease,” some aspects, such as the storage and streaming of data, are the same regardless of which disease the technology is used for, said Worrell, who was involved in creating the first-generation technology behind the device.
The technology behind these devices stems from a procedure known as deep brain stimulation. Commonly used in Parkinson’s disease, a neurosurgeon would apply an electrode — a small device that conducts electricity — on a specific neurological region of the brain and then provide an electrical stimulation pattern with the goal of treating the tremor associated with Parkinson’s.
Devices, such as the ones that deliver deep brain stimulation therapies, are “just starting to have the ability to sense signals from the brain as well as provide this therapy, and that’s opening up a really exciting new scientific space,” Borton said.
“No one really understands specifically how those (deep brain stimulation) therapies are working, and so with the sensing technologies in these new devices, … we can start recording signals from the brain while we’re delivering therapy,” he added.
At the Mayo Clinic, Worrell has overseen the implantation of this device in canine and human patients with drug-resistant epilepsy at the University of California, Davis and Mayo Clinic, respectively. For these patients, “the device is not only detecting seizures, but (it is) also forecasting seizures” and identifying when patients are at increased seizure risk, Worrell said. “In the future, we think this will be very useful to keep seizures from happening.”
The data from the device is streamed from the implant to a handheld device, such as an Apple Watch or iPhone, that can then be transferred for analysis, Worrell said.
“One of the barriers to research in this field is that every time you want to implant a new device into someone, you have to rewrite all of your software from scratch,” said Bradford Roarr, a senior research software engineer at the Center for Computation and Visualization who works in the Borton Lab at Brown and for the OpenMind consortium. To address this challenge, Roarr is working on a software library that would allow an engineer to write code for one device that could then be used for many others.
The consortium also hosts public workshops and presentations about their work for individuals in the field, such as weekly seminars that discuss translational neurotechnology. The public meetings have included up to 100 people from 20 different institutions. “It’s really quite a vibrant community,” Borton said.
The Borton Lab also integrates Brown undergraduate students in the projects related to the OpenMind consortium. Ivo Su ’23 is a neurotechnology software engineer who is writing the front-end of a software package that is being used with the consortium and other groups, Borton said.
“This has been a great opportunity for me to learn,” Su said. “As a front-end developer, I work with the interface that the user will interact with in the final (application).”
Su’s work demonstrates that undergraduate research and engagement in laboratories can “impact a pretty broad space,” Borton said.
Worrell said that the OpenMind consortium is “a fantastic opportunity” for investigators to observe projects at various institutions and participate in “open discussions about fundamental aspects of how we use these technologies and how they impact patients.”
“The time, … resources and capital to come up with new therapies for brain disorders and diseases is astronomical,” Denison said. “It’s really hard to find people who will invest in it and see it through to the end.”
The OpenMind consortium has served as a platform of researchers through which they can create “more efficient ways to perform clinical neuroscience,” Denison added, “and then ultimately translate that into better therapies.”
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