Future of Personal Monitoring Devices for Epilepsy

In an effort to improve the quality of life for patients and families affected by epilepsy, researchers at the American Epilepsy Society's (AES) 69th Annual Meeting unveiled personal monitoring devices in the works that aim to detect seizures before they even occur.

According to Mark Lehmkuhle, PhD, a neurosurgery professor at the University of Utah, random seizures are a harsh reality for the more than 1.2 million Americans with uncontrolled epilepsy.¹ The fear of unpredictable episodes can shadow every part of these individuals’ lives because of the uncertainty of knowing when they might strike and cause them to lose consciousness.

Each of the devices presented at the meeting offer biometric recording technology that would allow individuals to monitor clinical and subclinical seizure activity in their everyday home environment and receive an advance warning before a seizure strikes.

Researchers say the most common method used to record seizure activity outside of the hospital is the seizure diary. However, Dr. Lehmkuhle said, seizure diaries merely serve as snapshots and do not produce complete, accurate records. That’s because the diaries, he said, minimize the occurrence of non-convulsive seizures and lack records of seizures that occur while an individual is asleep.

With the intent to revolutionize the detection and treatment of seizures, Dr. Lehmkuhle and his team of researchers from the University of Utah and Epitel Inc., developed an inexpensive, disposable, and discreet seizure-monitoring device called the EEG PatchTM. This waterproof patch relies on 2 electrodes to record electroencephalogram (EEG) data during all aspects of everyday life.

He explained that an epileptologist must place the device on a patient’s scalp at a known seizure-prone area of the brain identified by a traditional, wired EEG. This device can operate for 7 days on a single charge, and data can be downloaded anytime for review in the standard European Data Format. A small handheld device can also be used to wirelessly observe the EEG signal in real time.

 “Armed with 7-day, location-specific EEG data, an epileptologist will have a robust record of quantitative seizure counts to better treat patients, revolutionizing therapy,” said Dr. Lehmkuhle. This device is currently being tested in a small pilot feasibility study and follow-up data will be released in the future.

In a second study,² a team of US researchers described a new device-designed to be worn around the arm-that is capable of detecting and recording generalized tonic-clonic seizures. Results from a phase 3 study revealed that this device, known as the Brain Sentinel: GTC Seizure Detection and Warning System, can detect seizure activity with 100% sensitivity and a very low rate of false detection, as compared to video EEG detection in epilepsy monitoring units at 11 level 4 epilepsy centers across the United States.

According to the authors, the system sends alerts within an average of a few seconds after the onset of the generalized tonic-clonic seizure. This device is currently under Food and Drug Administration review for market clearance.

Lastly, a research team³ from the University of Texas at Dallas tested the accuracy of 2 commercially available wrist-worn devices that detect seizure activity based on changes in an individual’s heart rate, arterial oxygenation, and electrodermal activity. Their results found that seizure detection using heart rate, arterial oxygenation, and electrodermal activity signals is much more accurate than detection by heart rate changes alone.

“These findings may allow for the development of a comfortable, easy-to-manage wrist-worn device capable of recognizing seizures, alerting a caregiver, and creating an electronic diary for use by physicians,” said Diana Cogan, a graduate student and lead author of the study.

Because sudden expected death in epilepsy (SUDEP) cases most often occur during sleep, researchers agreed that individuals who experience seizures overnight could greatly benefit from having a monitoring device to let others know when and if a seizure occurs.

All three presenters discussed the issue of stigmatism in epilepsy. “I think all of us who are working on devices are acutely aware of the stigmatism of wearing the cap on the head,” said Cogan. “That’s why we chose the biosignals we did – so the device can be worn on the wrist.”

Dr. Cavazos agreed, stating, “The advantage of having the device on the arm is that it’s not stigmatized. It allows people to move and do things. It's an exciting time for people with epilepsy.” His company hopes to make their device smaller and even more unobtrusive.

The AES 2015 Annual Meeting was held December 4-8 in Philadelphia.

References:

1. Lehmkuhle M, et al. Development of a discrete, wearable, EEG device for counting seizures. Abstract No 2.158, 2015. American Epilepsy Society Annual Meeting, www.aesnet.org.

2. Cavazos JE, et al. Automated EMG based seizure detection and quantification for the home and the epilepsy monitoring unit: a prospective multicenter study. Abstract No 3.088, 2015. American Epilepsy Society Annual Meeting, www.aesnet.org.

3. Cogan DL, et al. Seizure detection by multi-extracerebral biosignal analysis. Abstract No 3.084, 2015. American Epilepsy Society Annual Meeting, www.aesnet.org.