The Embrace Watch for Epilepsy

The Embrace2 watch is an FDA-cleared smartwatch that can be worn as a seizure alert system for children and adults. It detects some types of seizure and sends an alert signal to your designated caregivers, notifying them that you need help.

The Embrace2 watch uses technology developed by Empatica, an affective computing company that was spun-off from the Massachusetts Institute of Technology (MIT). The product was developed in partnership with the Epilepsy Foundation and private donors. It first received FDA clearance in 2018 and is considered a Class II, or moderate risk, medical device.

Indications

The Embrace2 watch can be used as an adjunct to medical management for people who have convulsive seizures due to epilepsy. These types of seizures are also described as generalized tonic-clonic seizures.

Convulsive seizures are characterized by rapid, rhythmic, involuntary (not on purpose) physical movements, usually lasting for several seconds. Convulsive seizures typically cause a decrease in the level of awareness, with or without complete loss of consciousness. The Embrace2 watch is used to send a message when it recognizes that the person wearing the watch is having a generalized tonic-clonic seizure.

How the Embrace Watch Works

Embrace2 is programmed with built-in sensors that gauge electrodermal activity (EDA). EDA refers to skin conductance—the ease with which an electrical signal travels through the skin—which, in turn, is related to the amount of sweating that occurs.

A 2012 study reveal fluctuations in the skin happen in response to the alterations that occur in the brain when you experience a convulsive seizure.

The skin changes are also especially likely to occur in response to the types of seizures that shut down breathing. These types of seizures can cause sudden unexpected death in epilepsy (SUDEP), one of the most serious consequences of epilepsy.

The built-in detectors include:

• EDA sensor: Measures sympathetic nervous system activity, which is activated during many circumstances, including convulsive seizures
• Gyroscope: Measures rotational speed
• 3-Axis accelerometer: High-sensitivity motion detection
• Peripheral temperature sensor: Measures skin temperature

Embrace also uses two applications:

• An event detector: This detects your electrodermal response. A machine-learning algorithm is trained to detect measures of convulsive seizures and is customized based on your history. The event detector sends an alert to your companion when the watch detects changes consistent with your seizures.
• A diary application: Used to monitor your everyday routines, alerting you if your activity, such as lack of sleep, puts you at risk of having a seizure

How Embrace Connects to Your Caregivers

Embrace sends data to a patient's smartphone using Bluetooth and then sends the information from the smartphone to the caregiver's smartphone via Wi-Fi or a cellular connection.

How to Use the Embrace Watch

You use the watch by wearing it on your wrist, especially at times when you may be at risk of having a convulsive seizure.

Once the Embrace watch detects a seizure, it sends data to an Alert App in the user’s smartphone that should be located within 30 feet (10 meters) of the patient. The Alert App then sends a text message and calls the designated caregiver(s).

In order to use an Embrace watch, it is necessary to have an active subscription to the monitoring and alerting service.

Limitations

The Embrace watch might not detect every convulsive seizure, and, subsequently, it might not send alerts. It cannot prevent you from having a seizure, or stop a seizure from happening, or protect you when you have a seizure.

Therefore, despite using your Embrace watch, you should continue to regularly take your anticonvulsant medication as prescribed. You should also avoid seizure triggers such as sleep deprivation, alcohol, and drugs.

If you have a tendency to have seizures, you should heed your healthcare provider’s instructions about driving and operating machinery, and avoid swimming alone or using a ladder. The alert system cannot protect you from these dangers.

If you are living with epilepsy, there are several approaches to staying safe. The Embrace watch uses technology, while another approach, such as getting an epilepsy dog, uses the companionship of a trained dog to help alert you and your caregivers when you are having a seizure. You can decide, along with your family, which method or combination of methods is right for you.

Cost and Availability

The Embrace watch is considered a medical device in the United States and Europe. At the current time, the monitoring and alerting system are available in certain countries.

You can buy the watch from the manufacturer, Empatica. The watch costs $249 and the monitoring service requires a monthly subscription, which costs either $9.90 per month, $19.90 per month, or $44.90 per month, depending on several features such as the number of caregivers to be notified.

All of the plans include alert service for at least one companion, as well as seizure detection, monitoring of sleep and physical activity, manual seizure logging, and the ability to access seizure history. The higher cost plans include rest mode detection, which may detect milder seizures, and alert location, which alerts companions to your location using GPS, as well as the ability to have additional companions (with the $19.90 plan) or unlimited caregivers (with the $44.90 plan).

The watch comes in several colors, and you can buy additional watchbands and a charging dock.

Correction - November 1, 2022: This article was updated to clarify that the Embrace2 is a medical device that received clearance from the FDA rather than approval.