A wristwatch-style device may soon help allay a major fear among people with epilepsy: That a seizure could occur without the knowledge of someone who could help. “We are working on a device called the SmartWatch that will detect myoclonic and grand mal seizures within 4-5 seconds after onset and alert caregivers within 7-10 seconds after onset,” said Stanford University pediatric neurology professor Donald Olson, M.D.
With San Jose, California-based Smart Monitor, an entrepreneurial offshoot of video security company Intellivision, Olson—who directs the Clinical Neurophysiology Laboratory at Stanford’s Lucile Packard Children’s Hospital—has completed a fully-functional prototype ready for Food and Drug Administration approval.
SmartWatch detects “certain kinds of abnormal movement, then signals a smart phone, cell phone, e-mail, laptop or other device,” Olson explained. “It can notify a caregiver within seconds that a seizure has occurred.”
The device should allow caregivers and family members both rest and respite, knowing that even in bed at night, the SmartWatch will alert them to seizure activity, he said.
The partners received grant support from the Epilepsy Foundation and the Epilepsy Therapy Project which helped them complete a clinical trial; add Bluetooth, a wireless technology for exchanging information over short distances; and make improvements to software that interprets motion signals.
During the trial, “SmartWatch missed only one out of eight convulsive seizures,” among patients admitted to the Stanford Medical Center for seizure monitoring, Olson said. A small malfunction, since fixed, caused the single miss.
Sight to sensation
Until SmartWatch, Intellivision specialized in video security monitoring.
But an unusual request from the mother of a teenager with epilepsy sent Anoo Nathan and her company on a new course.
“She asked us if we could somehow monitor her son during the night when he was asleep,” Nathan explained. “But it turned out to be an insurmountable challenge for video. It’s hard to keep track of a person’s movement in the dark, underneath blankets or sheets. For video to work, the subject has to be in the camera’s full field of view.”
But that didn’t dissuade Nathan and husband Vaidhi— Intellivision’s president and CEO—from pursuing the idea. In 2007, they filed a patent application for a device that detects abnormal motion, but not with a camera. Instead, tiny gyroscopes, accelerometers and computer algorithms sense and analyze bodily motion directly.
“The SmartWatch is primarily worn on the wrist like a watch, but can be worn on the arm, leg or ankle of patients whose abnormal movements are more pronounced there,” Nathan explained. “It’s fully portable and can be worn in and out of bed, during sleep or waking hours. It continuously monitors movements, analyzes them for abnormality and issues alerts.”
To make the device “cool” and socially acceptable, Nathan envisions streamlined versions born of 21st century product design. “The SmartWatch will evolve,” she said. “We envision several versions.”
Prediction vs. detection
With a built-in memory that can record the time and duration of a clonic or tonic-clonic seizure, the SmartWatch promises not only more independence, but more information, Olson explained.
“It can produce a complete archived record of all seizure activity—when and how often seizures occur, and how long they last,” Olson said. “We encourage patients and their families to keep track of seizure severity and duration, mostly for medication purposes. The SmartWatch will do this automatically, and with more precision.”
That promise is one of many reasons Olson found the concept attractive. Neurologists and epileptologists are often skeptical about interventional devices, particularly those that promise seizure relief or seizure prediction.
“Seizure prediction is the holy grail of epilepsy research,” Olson said. “But it’s still a long way off. SmartWatch isn’t about prediction—it’s about detection.”
But motion detection isn’t infallible, cautions epileptologist Rama Maganti, M.D., who directs the Barrow Neurological Institute electro-neurodiagnostics department at St. Joseph’s Hospital and Medical Center in Phoenix.
Likening the motion-detecting SmartWatch technology to actigraphy—a non-invasive way to monitor human waking/sleeping cycles with a wristwatch-style actimetry sensor—Maganti said that, as with any motion detector, “there will be a lot of false positives.”
High tech health
Spinning off a health technology like SmartWatch from a high technology company like Intellivision involves major new challenges, Nathan explained. “The similarities between the two companies start—and end—with technology. Nothing else is at all the same.”
Health care devices face regulatory hurdles, intensive capital demands and long product timelines, unlike pure tech products such as a PC or an iPhone.
“Six months to one year might be a normal product development cycle in tech,” Nathan said. “But some medical devices take 10 years.”
To move more nimbly through the system, Nathan envisions launching SmartWatch in two phases, first as a simple abnormal motion detector, “without any claims involving epilepsy, seizures, or its efficacy as a medical device.”
A second, medical device phase will launch after Nathan and Olson test the device on at least 35 epilepsy patients. A European launch and the quest for insurance reimbursement approval are also in the works.
“We have a product that provides a compelling case for neurologists, physicians, caregivers and most of all, people with epilepsy,” Nathan explained.