What if your watch could alert you to a seizure ahead of time so you could get to safer ground or ask someone to call 911? Or if a wristband could detect changes in the progression of your Parkinson's disease, allowing your doctor to adjust your treatment plan? What once seemed like science fiction is now reality for more patients with epilepsy and other neurologic disorders, as wearable electronic monitoring and alert devices paired with mobile phone apps enter the market.
Unlike old-fashioned methods of data collection, which rely on handwritten patient logs and calendars, these wristbands and smartphone apps record events and changes in real time, revealing a more comprehensive and objective portrait of daily symptoms. "With this more precise information, we can often spot problems even before a patient is aware of them," says Joseph I. Sirven, MD, a professor of neurology at the Mayo Clinic in Phoenix, AZ, a Fellow of the American Academy of Neurology (FAAN), and a member of the Neurology Now editorial advisory board.
The first generation of these devices was developed for patients with epilepsy, both by researchers and by small startup companies or garage-based operations whose founders had a loved one with the condition. Early prototypes alerted family members via smartphone that a seizure was happening. Today, more sophisticated devices can detect impending seizures or track changes in walking and other symptoms in patients with movement disorders.
Refining Seizure Treatment
People with epilepsy typically see their doctors about once every three months. If their symptoms worsen, doctors may prescribe a different anti-seizure drug, just to try something new, says Robert Fisher, MD, PhD, FAAN, the Maslah Saul MD professor of neurology and director of the Stanford University Epilepsy Center and a consultant for wearable technology companies, including Smart Monitor, which has created a smartwatch that alerts patients and family members to a seizure.
Wearable devices can provide better, objective data about when and how often seizures occur and on which medication, says Dr. Fisher. "We are on the edge of obtaining, for the first time, a reliable and truly accurate record of seizure activity day or night using this new technology."
And the devices continue to improve. At the Massachusetts Institute of Technology, for instance, researchers are testing a watch that measures changes in skin moisture that may reflect abnormal electrical signals in patients with complex partial seizures. (Complex partial seizures typically last less than two minutes and cause subtle symptoms such as involuntary vocal sounds or purposeless movements, but not convulsions.) Other devices being tested at a number of institutions use electrodes that are pasted to the scalp and worn for several days, which can measure early abnormal changes in electrical activity in seizure-generating areas of the brain.
Still other companies are trying to develop similar electrical activity monitors in the form of headbands and skullcaps that can be worn under a hat or ballcap.
Monitoring Motor Symptoms in Multiple Sclerosis
Last year, Biogen, a biotechnology company that manufactures multiple sclerosis (MS) treatments, partnered with Google X to study the Fitbit, a wristband that measures motor activity such as the quality and pace of walking and coordination, to see if it can be used to understand the variable nature of MS progression. Last year, the company gave Fitbit wristbands to 250 MS patients to track their activity and sleeping patterns and partnered with investigators at the Cleveland Clinic to develop an iPad app that could track changes in these patients. However, the bands are still not sophisticated or sensitive enough to provide consistently accurate data, according to the company.
Biogen is also working with researchers at Imperial College London on a three-year project to develop tools for collecting and integrating data such as brain scans, genetic markers in the blood caused by specific mutations, self-reported quality of life measurements, and movement tracking information into a single database.
In a study published in the journal Bio-Medical Materials and Engineering, researchers used wireless sensors attached to special insoles that relay data to smartphones to measure how well eight MS patients could walk or perform routine physical tasks compared with six healthy individuals. The researchers found meaningful differences in a number of walking measurements in the MS patients—data that could be used to evaluate gait degeneration in MS.
Researchers are also experimenting with similar technology in patients with muscular dystrophy to measure and record the progression of symptoms, which could help doctors better assess dosage and types of medications.
In another study published in 2014 in the Journal of Visualized Experiments, researchers at the Cleveland Clinic attached Apple iPads to the backs of MS patients while they walked and completed cognitive performance tests in order to measure MS-related disability and cognitive processing speed. A specially designed attachment used small metal pegs to measure patients' dexterity and how quickly they responded to a therapist's direction to perform certain tasks. The researchers hope this test will provide more precise data on walking speed, balance, and manual dexterity in MS patients, which would allow physicians to better track the progression of the disease and assess how medications are working.
Promising Systems for Parkinson's
Investigators at Intel Israel recently partnered with the Michael J. Fox Foundation for Parkinson's Research to develop a computer system that can process roughly 300 observations of daily living activities per second in patients with Parkinson's disease. The data are gathered using a smartwatch linked to a smartphone. An analysis of these observations—such as how easily patients can rise from a chair or a bed, lift objects, open jars, or use appliances—can help physicians assess disease progression and how effectively the condition is being managed. So far the platform has been tested in only a few patients at medical centers in Massachusetts, New York City, and Tel Aviv, but this year hundreds of patients in the Netherlands are participating in a larger clinical trial.
Even technology giant Apple is experimenting with ways to improve the monitoring and management of neurologic conditions. In April, the company announced the launch of ResearchKit, a software platform that uses iPhone apps to collect patient data. ResearchKit includes an app called Parkinson mPower, short for "Mobile Parkinson Observatory for Worldwide, Evidence-based Research," which was developed by Sage Bionetworks, a nonprofit in Seattle, in partnership with a number of leading neurology research centers.
The mPower app measures dexterity by tracking how fast people can type into their iPhones. Users can also record their voices at different points during the day, which could help researchers detect subtle changes like tremors that may indicate a worsening of symptoms. Using the iPhone's built-in GPS and accelerometer, the app can also measure a person's mobility and balance. The app is currently available for download through the Apple App store, and the data it gathers will be used as part of a study on dexterity, balance, gait, voice, and memory in people with Parkinson's disease.
Awaiting FDA Approval
To date, the US Food and Drug Administration (FDA) has not granted official approval to any of these devices, so they cannot claim to improve the detection of neurologic conditions. But some of these companies and research groups have already submitted data to the FDA for review.
Here's a more detailed look at some of the available and upcoming devices.
The BioStamp
A flexible adhesive device the size of two postage stamps, the BioStamp can be applied to the skin like a large Band-Aid. The device, which was developed by MC10, a startup in Cambridge, MA, contains sensors that collect data on movement and activity in the brain and muscles, which is then wirelessly uploaded to a nearby smartphone.
Last year MC10 partnered with UCB, a Belgian biopharmaceutical company, to further develop and test the BioStamp for use in epilepsy and other neurologic disorders. The hope is that it will help monitor disease progression and manage symptoms, allowing doctors to provide patients with more personalized care, according to co-founder Ben Schlatka. It could also help clinical research by providing better insight into the real-world impact of treatments.
Price: Not yet commercially available. The device was a finalist in the 2014 Epilepsy Foundation's Shark Tank competition, and BioStamp is currently working with the foundation and potential investors to begin clinical trials with epilepsy patients.
Embrace
This smartwatch was developed by Empatica, Inc., a wearable health technology manufacturer co-founded by Rosalind W. Picard, ScD, the founder and director of the Affective Computing Research Group at the Massachusetts Institute of Technology. The device can detect seizure activity in the brain via changes to the skin's electrical activity. When it detects early seizure activity, the device sends an alert to the wearer, as well as any friends or family members who are wearing a companion watch.
Insurance does not currently cover the Embrace watch, and the device only detects unusual or involuntary motor activity, which occurs in tonic-clonic or convulsive seizures but not in absence seizures, in which a person spaces out for a few seconds. But, the company is working with researchers to find out how the device might be used to detect non-convulsive seizures, particularly complex partial seizures, which cause such symptoms as lip smacking, fumbling, wandering, or being unaware of one's surroundings.
Price: $199, with an estimated delivery date of December 2015.
Brain Sentinel
Based in San Antonio, TX, Brain Sentinel has developed a device that uses electrodes attached to the biceps to detect signs of tonic-clonic seizures, which involve a loss of consciousness and violent muscle contractions.
"This device allows detection of seizure types that either start in the motor cortex, the area of the brain that governs movement, or start elsewhere and migrate to this area," says Jose Cavazos, MD, PhD, a professor of neurology at the University of Texas Health Science Center, director of the Epilepsy Center of Excellence at the Audie L. Murphy Memorial VA Hospital in San Antonio, and a consultant for Brain Sentinel. "Our system is designed specifically for detecting tonic and clonic phases of generalized seizures, not partial complex seizures, which are more limited and do not spread to other parts of the brain."
The company has submitted data from a large multicenter effectiveness study to the FDA for review. "If approved for detecting these seizures, physicians will be able to review the data and take better, more targeted action," says Dr. Cavazos. "This is data they've never had access to before."
Price: Not yet commercially available. A phase 3 clinical trial is currently underway to test the effectiveness of the system. Another smaller trial comparing the system's ability to detect seizures to observations by neurologists began earlier this year, with preliminary results expected in 2016.
SeizAlarm
This app uses an iPhone or Apple Watch to send a request for help to emergency contacts when a seizure occurs. It also has a log function that keeps track of seizure activity. Users can set the watch either to request immediate help or to issue a delayed warning, designed for individuals who experience simple partial seizures that do not typically result in a convulsive event. If an episode becomes more serious and the user has not disabled the warning after a pre-specified period of time, the device sends out an alert to emergency contacts via text, email, and phone with the user's GPS coordinates.
Price: Free on the Apple app store, including a help request service for a limited period of time, after which the service will be available on a subscription basis for a yet-to-be determined monthly fee. In the near future, SeizAlarm will also use the iPhone's motion sensors to detect convulsions, and will send out requests for help automatically if the wearer suffers an unexpected convulsive seizure.
The SmartWatch
Developed by Smart Monitor, a startup in San Jose, CA, in 2012, the SmartWatch alerts patients and family members to a seizure. More than 60 percent of the devices are worn by patients under the age of 21, and many families report that the watch helps track nocturnal seizures, which often go undetected. The company is currently sponsoring clinical trials in hopes of obtaining FDA approval for seizure detection.
Price: $149 for the Silver model with a one-time activation fee, plus a $19.99 monthly subscription fee. $199 for the Gold version, which includes GPS, alerts to more than one person, and a medication reminder function, plus a $29.99 subscription fee.