Introducing the Embrace Clinical Trial
Dear supporters,
We have great news for you! Our clinical trial “Embrace: Seizure Characterization” has been approved by the New England Institutional Review Board. It will examine the long-term effectiveness of our Embrace Alert System (Embrace watch and Alert app) for detecting and alerting to convulsive seizures. We also aim to better understand the relationship between daily activity, sleep, emotional state, medication adherence and epilepsy symptoms. These steps are valuable ones to earn FDA clearance and we hope they will help advance scientific progress in the epilepsy research space.
In this article you will discover what is important for you to know about the clinical trial. We also give a brief update on how the Embrace production in Korea is going.
What is the study about?
The study is designed to test the effectiveness of our novel seizure detection and notification system.
Empatica has been developing the world’s first method for seizure detection based on multiple kinds of physiological data sensed from the wrist. Most devices on the market detect only motion. We run advanced machine-learning methods to recognize patterns that are complex.
Our secondary goal is the exploration of the relationship between seizure activity, sensor data, and information from an electronic diary.
We hope the information gained will lead to the improvement of daily life for people living with Epilepsy so they receive help when they need it, and have more freedom to carry out daily activities on their own.
How can I enroll?
Enrollment in the study is free and voluntary for US residents who ordered an Embrace or will receive a donated Embrace. A participant may withdraw at any time.
Click here to access your Empatica Account and enroll
Enrolling in the clinical trial will allow you to: use the Alert app, receive full support if any incident occurs, help epilepsy research by deciding to share your data with academic institutions, and receive additional months of Alert premium service for your participation. Minors under 18 can enroll with their parents. Even if you do not have epilepsy, you can help the success of the clinical trial by enrolling and providing data as a control group.
We are actively working to expand the clinical trial outside US where governmental regulations permit.
Regulations say that the Embrace Alert System cannot be used outside the clinical trial.
While we work towards gaining regulatory clearance, the Embrace Alert System will only be available to clinical trial participants. You’ll still receive your Embrace if you don’t opt-in or are outside the United States, and are welcome to use it with the Mate app — a new e-diary app that we will launch at the end of next month. This app will allow people with epilepsy to better understand how seizures will interact with their physical activity, autonomic stress and rest.
Embrace production
We will start shipping the announced batch of Embrace watches in two weeks.
[caption id=”attachment_439" align=”aligncenter” width=”750"] The production line in Korea that is building the Embrace Flamingo Pink[/caption]
We’ve been working long hours with our production partners in South Korea to overcome the many challenges of testing such an ambitious new technology. It has been incredibly hard to get so many complex issues resolved so we can pass a huge list of tests. These issues delayed the shipment by three/four weeks. Now the situation is under control and we are pushing to prepare the production line for the next bigger shipment. The deadline for fulfilling all pre-orders by September is still valid, check our previous blog post for more info.
[caption id=”attachment_443" align=”aligncenter” width=”648"] The preview of the Embrace Packaging[/caption]
We created some great guides for you to better understand the clinical trial. You can start by reading the article “What is a clinical trial?” and then delve further into this subject with our support center sections:
- Clinical trial enrollment and general information
- Clinical trial monitoring with Embrace (medical oriented questions)
Feel free to email us with any questions or feedback. Also note that for privacy reasons, questions and comments related to our clinical trial should be addressed privately via email epilepsy-research@empatica.com and not on public platforms.
The Empatica Team
Disclaimer
Embrace is not a medical device and Empatica does not give medical advice. While the method used inside Embrace has been trained with lots of data from hospitals, the clinical trial will test how Embrace and Empatica apps work for convulsive seizure detection in the real-world.
