NeurologyLive® Top Stories of 2021: Epilepsy

The world of medical and clinical news was alive with updates on the development of new agents, FDA decisions on promising therapies, and research into better understanding disease pathology and patient care in 2021. As these news stories broke, the NeurologyLive® team was working tirelessly to provide succinct coverage of the through lines by offering the latest information on announcements and insights from experts in patient care and from the industry to keep the clinical community up to date.

In epilepsy, a number of trends emerged in the field, with most aimed at improving the predictability of seizures to ensure better treatment optimization, but others included the approval of new therapeutic formulations. Additionally, and perhaps most critically, a potential biomarker for one of the least understood risks of the disease was identified.

To offer a look back on some of those stories—many of which are still continuing and will extend into 2022—take a look at some of the coverage provided by the NeurologyLive® team that was most-viewed this year. These stories just scratch the surface of our coverage in AD. You can read more news in Alzheimer and dementia, hear experts share insight on the top conversations in the field, and learn more about the ongoing discussions on our Epilepsy clinical focus page.

Click the buttons below to learn more about each story.

1. EEG Wearable Device System FDA Approved for Epilepsy

In January, BioSerenity announced that the FDA had granted it 510(k) clearance for its Neuronaute EEG System and IceCap EEG wearable device, which allows clinicians the ability to remotely monitor and access electrical brain activity of patients with epilepsy. The Neuronaute EEG system consists of hardware and software that acquires, displays, stores, archives, and transmits electroencephalogram (EEG) signals from the brain using a full 10-20 montage. Clinicians can receive notifications of specific events related to the patient while looking at live data visualization. Additionally, there is an extended battery life of 8 hours with a rechargeable battery.¹

Bruce Lavin, MD, MPH, chief medical officer, BioSerenity, said in a statement at the time that the company was “committed to improving patient care by making EEG diagnostics more readily available to the 3.4 million people in the USA alone who are living with epilepsy.”

This news kicked off 2021 and restarted the ongoing conversations about improving seizure monitoring and forecasting. In August, findings from a recent study indicated that automatic seizure detection using machine learning (ML) from multimodal sensor data was feasible to detect a broad range of epileptic seizures. Pediatric participants wore sensors on wrists or ankles, with ML models trained to detect all seizure types performing better than models trained to detect specific types but pointed to the need for further research should consider clinical chronoepileptological variables.

Later in the year, Jessica Fesler, MD, staff epileptologist and Cleveland Clinic’s Epilepsy Center, told NeurologyLive® that this area is of extreme interest to those in the field. “One of the hardest things for people living with epilepsy is the unpredictability of seizures. We call seizure forecasting basically the Holy Grail. If we could help people predict when their seizures were going to happen and they could take action, it could change the quality of their life. With the emergence of wearables, smartwatches, and other type of wearable sensors, pairing those with an app that auto logs, could maybe open the door that could alert caregivers or emergency services,” she explained.

2. FDA Approves Brivaracetam for Partial-Onset Seizures in Pediatric Epilepsy

At the end of August, the FDA approved an expanded indication for brivaracetam (Briviact; UCB Pharma) CV tablets and oral solution, a treatment for pediatric patients with partial-onset seizures. The indication included an intravenously (IV) administered formulation, for when oral administration is temporarily not feasible—making it the first IV agent for this indication in nearly 7 years.¹

This approval gave the third-generation antiepileptic racetam derivative and 4-n-propyl analogue of levetiracetam (Keppra; UCB Pharma) utility as both monotherapy or adjunctive therapy and is administered in tablets, oral solution, and IV dosage forms. At the time of the approval, Mike Davis, head, Neurology, UCB, said in a statement that, "When a child or infant suffers from epilepsy, we know that their life and the life of their caregiver is consumed by the unpredictable nature of seizures and the potentially profound consequences epilepsy can have on pediatric patients. We’ve leveraged UCB’s experience in epilepsy and commitment to innovation to expand the indication for BRIVIACT to reduce the number of partial-onset seizures these young and vulnerable patients are experiencing and provide their caregivers with an FDA-approved treatment."

This was not the first time that pediatric epilepsy was brought up in conversation in 2021, particularly for patients with refractory epilepsy who cannot reap the benefits of these therapies. Earlier that same month, NeurologyLive®’s August issue guest editor-in-chief Jurriaan Peters, MD, PhD penned a piece calling for a reexamination of the outcomes used for pediatric patients who undergo surgery. Peters wrote that “although the developmental benefits follow the surgical reduction of the seizure burden, the current outcome metrics do not capture the broader goals of epilepsy surgery. Such goals include optimizing neurodevelopment, preventing the epileptic encephalopathy, and improving the quality of life for our patients and families.”

Similarly, a number of data have been published in the latter half of 2021 that suggest a ketogenic diet might aide those younger patients with refractory disease. Results from a recent prospective study at a single center in Argentina suggest that ketogenic diet therapy (KDT) was effective and well-tolerated in infants with treatment-refractory epilepsy. Although adverse effects (AEs) were commonly reported, they did not provide reason to discontinue treatment, investigators found. Lead author Marisa Armeno, MD, Ketogenic Diet Team Coordinator, department of clinical nutrition, Garrahan National Pediatric Hospital, Buenos Aires, Argentina, et al wrote, “Our study confirms that KDT is a useful option in infants with treatment-resistant epilepsy. Further studies are necessary to evaluate in which epilepsy syndromes, beyond West syndrome, and etiologies the KDT is more effective, for early referral in order to start treatment earlier.”

3. Heart Rate Variability Identified as Potentially Crucial SUDEP Biomarker

In late November, data from a retrospective study spanning more than 10 years found an association between heart rate variability (HRV) and sudden unexpected death in epilepsy (SUDEP), marking a major moment for the field in better understanding an event that has perplexed epileptologists and their patients for years. In this largest SUDEP biomarker study to date, senior author Orrin Devinsky, MD, director, Comprehensive Epilepsy Center, NYU Langone, and professor of neurology, NYU Grossman School of Medicine, and colleagues compared HRV in 31 SUDEP cases and 56 controls who had video-EEG monitoring data.

"We need to do better. In addition to helping patients understand what their risk is so that we can treat them better, it’s also the ability to assess interventions,” Devinsky told NeurologyLive®. “If we were to get an intervention—let’s say, a watch that detected a seizure and gave out a lout alarm to awaken a post-ictal patient—then we would have to follow so many people for so long. That study would be prohibitively expensive. If only we had a biomarker that identified a patient that looks well controlled but is at high risk."

As SUDEP has been a major discussion point for years, unsurprisingly, the NeurologyLive® team had spoken with another expert earlier in the year about the challenges of addressing the event. Fabio Nascimento, MD, clinical fellow at Massachusetts General Hospital, has been helping to lead efforts that take an analytical approach to addressing gaps within epilepsy education. Using an emailed survey, he and colleagues found that less than half of national (44%) and international (41%) adult neurology trainees were educated about SUDEP, and the majority were unfamiliar with its risks and strategies to prevent it. The research included 171 adult neurology trainee respondents in the US and 171 respondents outside of the US.

Even earlier in 2021, in June, a group proposed a new inventory tool for predicting SUDEP, which was shown in a small study to demonstrate the limitations of the currently used SUDEP-7 inventory and better prediction of SUDEP. The novel tool includes weighting scoring for 3 items—generalized tonic-clonic seizures (GTCS) within the last year, any seizures within the last year, and intellectual disability—which can result in a score from 0 to 4. Notably, for each additional point gained on the SUDEP-3, the odds of SUDEP increased by 180%, compared to the per point odds increase of 40% associated with the SUDEP-7. In receiver-operating characteristic (ROC) analyses, the area under the curve (AUC) was 0.75 for the SUDEP-3 compared with 0.66 for the SUDEP-7. Model quality was also deemed better for the SUDEP-3.

REFERENCES
1. BioSerenity announces FDA clearance for electroencephalography (EEG) wearable device system. News release. BioSerenity. January 5, 2021. Accessed December 20, 2020. https://www.prnewswire.com/news-releases/bioserenity-announces-fda-clearance-for-electroencephalography-eeg-wearable-device-system-301200831.html
2. UCB Announces Briviact (brivaracetam) CV now FDA-approved to treat partial-onset seizures in pediatric patients one month of age and older. News release. UCB Pharma. August 30, 2021. Accessed December 20, 2021. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-briviact-brivaracetam-cv-now-fda-approved-pediatric
3. Sivathamboo S, Friedman D, Laze J, et al. Association of short-term heart rate variability and sudden unexpected death in epilepsy. Neurology. 2021;97(24):e2357-e2367. doi:10.1212/WNL.0000000000012946