FDA OKs Smart Watch for Epilepsy Patients

Embrace device detects grand mal, tonic-clonic seizures

The FDA cleared marketing for Embrace, a smart watch that helps epilepsy patients and caregivers monitor seizures.

The prescription-only device is the world’s first smart watch to be cleared by the FDA for neurology use, developer Empatica stated in a news release.

Embrace uses a seizure detection algorithm to recognize electrodermal activity patterns that are likely to accompany epileptic seizures. It monitors for grand mal or generalized tonic-clonic seizures and alerts caregivers through text and phone.

The device was tested in a clinical study of 135 epilepsy patients who were admitted to multiple epilepsy monitoring units for continuous video electroencephalography (EEG). Over 272 days, researchers collected 6,530 hours of data, including 40 generalized tonic-clonic seizures. Embrace detected 100% of the seizures, which were confirmed by independent epileptologists who made assessments without seeing the Embrace data.

“The FDA approval of the Embrace device to detect major convulsive seizures represents a major milestone in the care of epilepsy patients,” Orrin Devinsky, MD, of New York University in New York City said in the news release.

More than 3,000 Americans die each year from Sudden Unexpected Death in Epilepsy (SUDEP), he added. “The scientific evidence strongly supports that prompt attention during or shortly after these convulsive seizures can be life-saving in many cases,” he said.

Empatica, a MIT Media Lab spin-off, initially launched Embrace through a crowdfunding campaign in 2015. The company raised $782,666, more than five times its goal.

Embrace is the only FDA-cleared seizure monitoring smart watch that also tracks sleep, stress, and physical activity, the company noted. It has been approved in Europe to monitor seizures since April 2017.

New Warning System For Epilepsy Patients Could Save Lives

New Warning System For Epilepsy Patients Could Save Lives 1000 × 561

Epilepsy is a neurological condition that affects people of all ages and causes the onset of seizures.  These seizures can vary in length and severity from person to person, and learn to live with epilepsy is no easy task.  For many epilepsy patients, they can feel the onset of a seizure but often it is too late for them to take action to keep themselves safe.

However, scientists from the University of Melbourne and researchers from IBM, are now working on technology that may be able to assist epilepsy patients in recognizing the signs of an oncoming seizure earlier than they would normally have, giving them extra time to ensure their safety.  As of now, we are still unsure as to what triggers seizures to occur in those suffering from epilepsy.  Some studies have suggested that it could be stress related, others say that it may be down to tiredness or menstruation, but one thing that we can be certain of is that the activity in the brain must act similarly in all cases where a seizure is about to occur. 

So, the team set up a project called TrueNorth and involves designing a computer chip that will mimic the structure of the brain to allow accurate data analysis.  The participant of the tests was asked to complete a range of tasks which involved squeezing either the left or right hand while connected to an EEG that constantly detected their brainwaves and then used that data to train their system to predict which hand was doing the squeezing.  The results of these tests resulted in a 76 percent accuracy, but the researchers are adamant they can improve on this. 

New Warning System For Epilepsy Patients Could Save Lives
One of IBM’s TrueNorth neuromorphic chips.

What the team plans to do next with their research is to implant a sensor into an epileptic patient’s brain so that they can monitor their brain function constantly.  In doing this, over time, they will be able to formulate enough results of brain activity to predict when the seizures occur.  From here they can develop TrueNorth further to be able to assist those suffering from seizures to find a safe place to go when the machine recognizes the onset of a seizure and alerts them.

This really could mean the difference of a lifetime for some patients who are too terrified to go outside in case a seizure comes on unexpectedly.  Although it may still be quite some time before we see the finished version of TrueNorth hitting the stores, rest assured that help is on its way. 

Pain Complaints, Opioid Use Higher With Epilepsy

Individuals with epilepsy had insurance claims for opioid prescriptions and diagnoses of painful conditions that were substantially more common than in a control group of nonepileptic patients, according to a database study reported here.

Among 10,271 health plan members with a diagnosis of epilepsy in 2012, 26% had received an opioid prescription versus 18% of 20,542 members of the same plans matched for gender, age range, and insurance type (P<0.001), said Andrew Wilner, MD, of Angels Neurological Centers in Abington, Mass.

He also reported that the epilepsy patients had significantly greater rates of each of 16 pain-related conditions analyzed; overall, records of 51% of the epilepsy patients included diagnoses of at least one of these conditions compared with 39% of controls (P<0.05).

Wilner presented the findings during a poster session at the American Epilepsy Societyannual meeting here.

He said the study design didn’t permit firm conclusions about the potential links between pain syndromes, opioid use, and seizure disorders. But the findings may reflect increased likelihood of pain-related comorbidities that may accompany epilepsy, he said.

“Epilepsy is not [itself] a painful condition,” Wilner noted, but seizures can trigger falls and resulting injuries. He said previous studies had found fracture rates in epilepsy patients that were double those seen in otherwise similar individuals.

He conducted the study with researchers from the Accordant Health Services unit of CVS Caremark, which funded the analysis. The group used claims data in 2012 from members of nine geographically diverse health plans contracting with Accordant for epilepsy care management. More than 3.6 million people were served by these plans, of whom 10,271 had epilepsy and were eligible for inclusion in the analysis.

The control group was drawn from the same health plans and were matched 2:1 to the epilepsy patients. Plan members with HIV, any type of malignancy, various kinds of rheumatological and genetic diseases, and organ transplant recipients were excluded from the control group, in recognition of their greater-than-average use of healthcare services.

In addition to checking for records of plan-paid opioid prescriptions, Wilner and colleagues also counted diagnoses of such pain-related conditions as headache, sciatica, sinusitis, and joint pain — a total of 16 in all.

Wilner noted that, for many of these conditions, opioids are considered ineffective, but nevertheless these are commonly prescribed in ordinary practice. He said the point of the study was to get a snapshot of how epilepsy patients are diagnosed and treated in real life.

He said the increased rates of pain diagnoses and opioid use may result from seizures or other factors directly related to epilepsy. Alternatively, patients with epilepsy may have more frequent encounters with the healthcare system (these were not counted in the study) which, in turn, could make diagnoses of other conditions more likely, Wilner suggested.

But the bottom line, he said, was that the relatively high frequency of opioid use among the epilepsy patients deserves more research in order to identify the reasons and to determine the extent to which it is or is not appropriate.