Safety and epilepsy: What is Embrace® and how can it help keep someone living with epilepsy safe?
In this quarterly newsletter section, we will be presenting a new device that has come out on to the market of epilepsy safety devices (not yet FDA approved, but working on getting there). Embrace® can be described as "a groundbreaking wearable device designed to improve the lives of the people living with Epilepsy." It records physiological signals using its cutting edge sensors and provides information about the rest, sleep and activity information of the person wearing it. Embrace® is designed to also monitor and alert for tonic clonic (convulsive) seizures.
What is Embrace®®
Embrace® is a groundbreaking wearable device designed to improve the lives of the people living with Epilepsy. Embrace® records physiological signals using its cutting edge sensors: an EDA sensor, a Peripheral Temperature sensor, a Gyroscope, and Accelerometers. The device provides information about user's rest, sleep and activity information through the Mate app, which can also be used as a semi-automatic electronic seizure diary. Embrace® is designed to also monitor and alert for tonic clonic (convulsive) seizures.
Embrace® has received CE medical certification - which means that it has been cleared by the European Union as a medical device for "convulsive seizure detection". However, Embrace® is not yet a medical device in the United States because it is currently under consideration by the FDA. In the meantime, in the United States Embrace® for convulsive seizure detection can only be used as part of a clinical trial (in other words, research).
How does it work and does it require any additional equipment to use it?
Embrace® needs to be paired with a compatible smartphone that has access to the Internet. Users need to download 2 apps: the Alert and the Mate apps.
Embrace® records physiological signals to its internal memory and automatically sends them to the smartphone using a bluetooth connection. Then, via Internet connection, the signals are sent to the Empatica® servers.
When Embrace® detects an unusual event, such as a convulsive seizure, it sends an alert call/SMS to the caregivers indicated in the Alert app, provided that the Embrace® watch is connected to the paired smartphone via Bluetooth and the smartphone has access to Internet.
Users can add up to 5 caregivers. They can activate and deactivate caregivers based on their availability.
Would anyone with seizures be a good candidate for Empatica® or are there certain characteristics that are needed (e.g. seizures that involve bodily movements vs. loss of tone)?
Embrace® would be optimal to monitor and alert for tonic clonic (convulsive) seizures. The software that is being tested is optimized to detect events that involve both unusual motor activity and autonomic activation and as we know "unusual motor activity and autonomic activation typically accompany convulsive seizures."
Can it be worn at all times? Is it waterproof?
Embrace® can be worn continuously, except for when it needs to be removed from the wrist to connect it to the charger (for about 2 hours daily).
Embrace® is water resistant. It can be worn while swimming so long as it is not in salt water, such as the sea, ocean or salt water swimming pools.
How quickly does it pick up the occurrence of unusual motor activity and autonomic activation and communicate this information to the caregiver?
Embrace® normally picks up a convulsive seizure in about 15-20 seconds from the start of the seizure event and sends alert calls and SMS to the caregivers within 5-10 seconds.
Is there a way to use Empatica® to send out a help message even if a seizure has not occurred?
Embrace® doesn't have the functionality to manually send emergency alerts/help messages to the caregivers. The Alerts are triggered automatically by events such as convulsive seizures.
Tell us a little bit about how the idea of Empatica® came about? When and where were you founded? What was the need you saw that needed to be filled?
Empatica® was founded in 2011 and has headquarters in Milan and Boston. Our company has the honor of developing the world's smallest and most accurate wristband for medical research. The E4 wristband is used by leading hospitals and universities worldwide for advanced research studies on human behavior.
With the aim of bringing cutting edge technology from research facilities to people, in 2014, Empatica® launched a crowdfunding campaign for the Embrace® watch - a sleek wearable device designed to improve the lives of people living with Epilepsy. The campaign successfully reached the crowdfunding target of $100,000 in 24 hours and concluded after 60 days with $500,000 of funds.
Thanks to the generosity of its supporters, private donors and the Epilepsy Foundation of America, Empatica® was able to donate 1540 Embrace® watches to families and children in need.
Have you tested this product? Where? Results?
The device was beta tested on some of our earliest supporters for a few months before it was launched to all other users. The feedback from the beta testers allowed the company to fix a few bugs and add useful new features before the final launch in September 2016.
We also conducted a long-term (113 days) test of the Embrace®, during which the device was worn continuously outside the epilepsy monitoring unit (EMU). Embrace® detected 22 out of 24 of the patient's convulsive seizures (Sens=92%) with a false alarm rate of 0.35 false alarms per day worn. Most days had no false alarms. Only 2 of the 113 days had more than 2 false alarms/day.
In February, 2016, results of a clinical evaluation of the Embrace® monitor were presented at the Epilepsy Pipeline Conference Meeting. In June of 2016, results were presented at the Partners Against Mortality in Epilepsy (Onorati et al., 2016; Caborni et al., 2016). The studies can be summarized with the following:
In the first work (Onorati et al., 2016) the seizure detector achieved a sensitivity of 95% on 38 Generalized Tonic Clonic Seizures (GTCS) from 18 patients admitted to epilepsy monitoring units. Most of the patients (16/18 = 88%) had all of their GTCSs detected. Most of the patients (10/18 = 55%) had less than 1 false alarm every 2 days.
In the second work (Caborni et al., 2016), the seizure detector achieved a sensitivity of 100% on 12 seizures (8 GTCS and 4 Focal motor seizures) from 53 patients admitted to epilepsy monitoring units.
The seizure detector was able to provide an alarm before the seizure had finished in 100% of the cases.
False alert rate was 0.93 false alarms/day over 164 days of recordings.
40 patients out of 53 (75%) had less than or equal to 1 false alarm/day.
18 patients out of 53 (34%) had no false alarms.
How can someone purchase the Empatica®? Is there a website? Toll free number?
What is the cost of this product? Anything else we may have not asked, feel free to include.
Embrace® can be purchased directly on our https://www.empatica.com/ for the price of USD 249. This company is still composed of a small team and as a result are not able to offer phone support yet, however, they will be happy to respond to any inquiries via email at support@Empatica.com.
