Device Could Alert a Potential Deadly Epileptic Event Looms
Neurava has designed an initial prototype SUDEP detection device.
Subscriber Benefit
As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowImagine having a medical condition that elevates your risk for sudden death, but there’s nothing you can do about it—other than worry. A pair of Purdue University PhD students says that’s the harsh reality for some 1.2 million Americans who have refractory epilepsy, which puts them at risk for “sudden unexpected death in epilepsy,” called SUDEP. The team has filed a patent on a wearable device that can monitor for SUDEP—providing peace of mind, and potentially, a life-saving warning that SUDEP may be minutes away.
“Through our research, we learned that a lot of physicians don’t even discuss the risk for SUDEP with their patients, because there’s no solution to it; there’s no device that monitors their risk, so why cause more emotional distress to these patients, when there really isn’t a solution out there?” says Purdue Engineering PhD student Vivek Ganesh. “That’s something we really took to heart, and we really want to end by giving these patients a dedicated system that can continuously monitor their risk, so they can live a full life without worrying too much about it.”
The epilepsy complication kills about 4,000 Americans each year. Ganesh, along with Purdue Engineering PhD student Jay Shah, co-founded West Lafayette-based startup Neurava to commercialize the device, called N1. It would be the first device to monitor specifically for the life-threatening condition.
N1 is built upon a key discovery made in Dr. Pedro Irazoqui’s lab at Purdue, which uncovered a probable “mechanism of action,” or biological signals, that specifically identify SUDEP risk.
“The device monitors for biological dysfunctions that occur prior to a SUDEP event. There’s typically a mixture of a few different events, so there’s an identifiable pattern, and that’s what we look for,” says Ganesh. “Without getting too much into the details, we have a specific marker we’ve discovered through our research in the lab.”
Because more than 90% of SUDEP cases occur at night, the team designed the device to be worn around the neck while sleeping. The team says it also functions as a standard seizure monitor, but with an added layer of protection, because it also monitors specifically for SUDEP.
The device not only alerts the wearer, but will also contact the person’s caregiver with a variety of alert options, including a text, phone call or haptic, such as a vibration on a mobile watch or other device. The team says the device will detect and send the alert a few minutes before the onset of the potential SUDEP event. The intervention will vary for each patient, dependent on the unique characteristics of his or her epilepsy; some patients have an implantable device that delivers medicine or therapy to stop a seizure, and Ganesh says “intervention, typically in the form of CPR, has been shown to be 100% successful.”
“A lot of these patients are children, so parents have a really hard time taking care of their kids at night when they need to sleep. They’re not sure when seizures may occur, and they need to be alerted it’s potentially life-threatening, like SUDEP,” says Shah. “We talked to multiple parents who sleep with their children [who have epilepsy]. These parents are basically sleeping on-edge all the time; as soon as they feel something shake in the bed, they’re on alert making sure they’re ok, or is a seizure happening? This non-invasive, wearable device can really alleviate a lot of the emotional stress they suffer.”
Because N1 is a diagnostic device, and not a therapeutic one, the team expects FDA approval will not be difficult. The startup, which is partnering with the Purdue Research Foundation, is currently looking for non-diluted funding sources, such as grants from federal agencies, as well as angel investors or venture capital to complete regulatory approvals, clinical trials and commercialization.
“Right now, it’s a diagnostic device, but as we continue to develop it and enter the market, we’re looking also to go into the therapeutic route,” says Shah. “Not only are we going to be able to detect [SUDEP], but the device will also be able to—based on these alerts we’ve now identified—administer some sort of therapy. Either it’s an implantable version or even potentially a wearable version.”
Ganesh and Shah plan to pursue the project full-time after earning their PhDs, “because something like this requires our full attention,” says Ganesh.
“We both created this company for one reason: to create a device that can improve the quality of life for these epilepsy patients,” says Shah. “A lot of research doesn’t get out of the lab. With this technology and what we think we can do, we believe we can make a translational impact—take this technology from the lab and get it into the hands of people who truly need it to significantly improve their lives.”
Ganesh says monitoring babies at risk for SIDS (Sudden Infant Death Syndrome) could be a second future application for the wearable technology.
Shah says the device got its start when Purdue Reilly Professor of Biomedical Engineering Dr. Pedro Irazoqui “had a crazy idea.”