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.

Martin Elliott: We need to raise awareness of sudden death in the young.

Seven years ago, my apparently well 26 year old son, Toby, died in his sleep of SUDEP—sudden unexplained death in epilepsy. Undiagnosed, he had bitten his tongue, quite severely, in his sleep one year previously. It was devastating to us as a family and to his friends.

I had never heard of SUDEP. I was not alone; even in 2011, neither had 76% of Canadian paediatricians caring for people with epilepsy. [1] I knew, as a paediatric cardiac surgeon, that there were up to 1000 young victims of sudden cardiac death (SCD) each year in the UK, including famous footballing victims. I did not know of the similar annual number of SUDEP deaths. Nor did I know about the disparity in research funding (cardiac research has up to 10x more funding than epilepsy research), the social stigma associated with epilepsy (persisting from the days of locking epileptics in asylums), the unwillingness of many neurologists to discuss the risk of SUDEP with their patients, or the challenges a family faces when the place of death, often the home, is treated as a crime scene. Many SUDEP deaths occur at night, and the most common causes of death in the second and third decades include suicide and accidental drug poisoning. That is what the police must assume, and there is usually a post mortem and sometimes an inquest.

Over recent years, and largely because of pressure from bereaved families, research into SUDEP has increased. There are specialist teams, for example at UCL, part of  the NIH “Center without Walls” for SUDEP research, and there is now an Epilepsy Deaths Register in the UK, but overall awareness remains low. What is known is that there are established risk factors for SUDEP, including frequent, and or chronic generalised tonic-clonic seizure’s (GTCS), either no or high dose anti-epileptic drugs (AEDs), nocturnal seizures, prone position, women of child-bearing age, and recent changes in therapy. A proportion has no previous diagnosis of epilepsy.

The final common pathway for death is probably a ventricular dysrhythmia, perhaps induced by hypoxia in the postictal state. And research has demonstrated a potential 20% overlap with cardiac dysrhythmias associated with membrane ion channelopathies.

There is much to be learned from both SCD and SUDEP cases. Yet the quality of post-mortems is variable, and the attitude, communication skills, and efficiency of coroner’s services are also something of a post-code lottery. Of course, there are resource issues both in health and justice, as a result of austerity politics, but the mark of a civilised society is how it cares for its young, and preventing avoidable deaths is a laudable aim. Sadly, for epilepsy there is wide geographic variability in service provision, guideline application, quality of supervision, and access to specialist care. Epilepsy is not included in the 5-year forward plan.

Preventative strategies, ranging from alarm devices, implantable defibrillators, and better ADE control to alert dogs need thorough research. The search for a cause requires genetic and metabolic science and above all tissue/blood from victims and their families. Our systems should support this, and definitely not get in the way.

Based on my own experience and that of other families, it is my view that we still need to raise awareness of both SUDEP and SCD. Epilepsy services must be redesigned, with rapid access to expert care and the post-code lottery abolished. All newly diagnosed patients with epilepsy should have a cardiac assessment. Post-mortem quality should be improved and tissue sent routinely to expert teams, and all clinical history data should go into a register, for both SCD and SUDEP cases. All coroners should encourage the science, not hinder it.  A declaration of death by natural causes does not help.

Finally, bereaved families may need a great deal of support to get on with their lives. The effects never disappear. You don’t “get over it” or “move on”, you are, quite simply, changed.

Cardiological Factors On Sudden Unexpected Death In Epilepsy

Epilepsy is a group of neurological diseases characterized by epileptic seizures. Epileptic seizures are episodes that can vary from brief and nearly undetectable to long periods of vigorous shaking. Recently from the bits of research, the fact is coming in a picture that epileptic patients have a risk of unexpected death due to cardiological factors. This article entails the link between cardiological parameters and sudden death in Epilepsy. SUDEP is defined specifically as the sudden, unexpected, witnessed or unwitnessed, non-traumatic and non-drowning death in patients with epilepsy with or without evidence for a seizure, and excluding documented status epilepticus, in which post-mortem examination does not reveal a structural or toxicological cause for death.

This condition is referred as Sudden Unexpected death in epilepsy (SUDEP). The cause of SUDEP is not known. Observations in individual cases have suggested possible cardiogenic, pulmonary, and primary neurological etiologies. It may be that SUDEP is a heterogeneous condition. The vast majority of witnessed cases have been associated with a seizure, and the main risk factor is uncontrolled seizures, especially convulsions. Incidence: SUDEP causes between 2 and 18 percent of all deaths in patients with epilepsy. This proportion may be moderately higher in children, as high as 30 percent in one cohort study. The estimated rate of SUDEP is approximately 1000 person/year based on the studies which incorporated a small number of cases. The lifetime cumulative risk for SUDEP by age 40 has been estimated at 7 percent overall, or 12 percent in those with persistent epilepsy. The cumulative full lifetime risk has been estimated to be 35 percent Pathophysiology of SUDEP: There are several factors which are taken into consideration based on the different studies being carried out on sudden unexpected death in epilepsy.

While SUDEP is only rarely witnessed, most observations suggest that SUDEP occurs in the context of a seizure. No singular mechanism has been established, and multiple pathophysiologic factors may be involved, including cardiac arrhythmia, seizure-induced respiratory changes and pulmonary dysfunction, and neurogenic cardiorespiratory depression. The major factors are listed below Cardiogenic Factors Some indirect evidence suggests, cardiac arrhythmias and cardiovascular disease, may be involved some cases of SUDEP, some factors are described below Ictal bradycardia and asystole: Ictal Bradycardia and asystole can be observed and even asystole is observed in some patients with epilepsy.

There is a strong possibility that some cases of SUDEP can be explained by this phenomenon. However, the relationship between the ictal heart and SUDEP is not strongly established. But it is a noted that known cases of ictal bradycardia or asystole have an increased risk of SUDEP compared with those who do not have these features. The rate of bradycardia and asystole in patients with epilepsy is ambivalent One study monitored electrocardiogram using an implantable loop recorder for an average of 18 months in 19 months with refractory epilepsy. Four patients had bradycardia or periods of asystole, prompting subsequent pacemaker placement; three of these episodes occurred during a clinical. One more study reviewed the monitoring data on 1277 seizures on 69 patients identified 5 patients in whom ictal bradycardia occurred in 18 percent There was another study in which the ictal asystole was observed on a long term, EEG monitoring in 10 of 6825 patients (0.15%). This occurrence was not associated with cardiovascular risk factors or abnormal baseline ECG. Apparently, bradycardia and asystole in epilepsy patients are most commonly analyzed. There is a possibility that partial seizures are connected with ventricular tachyarrhythmias.

In one case study, a 51-year-old woman developed ictal ventricular tachycardia evolving into a ventricular fibrillation arrest acquiring resuscitation. Prolonged QT interval and Tachyarrhythmias The suggested mechanism in SUDEP is also characterized by Seizure-induced changes in the QT interval or autonomic instability, predisposing to the malignant arrhythmias. This mechanism is bolstered by the fact that some patients carry a pathogenic mutation in one of the genes associated with congenital long QT syndrome. Seizure-induced changes in the QT interval have been described, although their significance is not clear. A number of case series of combined EEG-ECG telemetry have noted prolongation of the QT interval during seizures in 12 to 23 percent of patients. This finding may be associated with potentially fatal ventricular arrhythmias. However, in a matched case-control study, a prolonged QT interval was not specifically associated with SUDEP Cardiovascular Disease A case-control study in Stockholm found a history of epilepsy is a risk factor for an acute myocardial dysfunction.

They tested 57 patients and found the correlation of the epileptic factors and cardiovascular disease. This supports the link of Epilepsy and cardiovascular disease. Respiratory Dysfunction Alternatively, ventilatory failure with ictal hypoxemia and hypercapnia from centrally-mediated apnea may underlie some cases of SUDEP; frank apnea is sometimes observed. There are many studies which provide the evidence of the clear link between the above-mentioned factors. The data suggested above clearly, mentions the link between the cardiological factors and Epilepsy. It is apparent to stay alerted while treating the Epileptic patients for SUDEP. The follow up with Epilepsy patients is helpful and monitoring the parameters mentioned above can be taken into a consideration while treating patients.