Abstract
Keywords
Background
Approximately 3.4 million people in the United States live with epilepsy, a chronic neurological disorder characterized by recurrent seizures. 1 Despite advances in antiseizure medications, roughly one-third of individuals continue to have inadequately controlled seizures, placing them at ongoing risk for traumatic injuries and sudden unexpected death in epilepsy (SUDEP). 2
In response, seizure detection/alerting devices (SD/AD) have emerged as a promising component of comprehensive epilepsy care. These SD/ADs include external wearables, noninvasive, home-based systems, and implanted systems that use physiologic or visual signals such as motion, electrodermal activity, audio, EEG, or other biosignals, to detect seizures and alert caregivers or healthcare providers.2-8 Beyond enabling faster intervention that may lessen the severity of seizure-related complications, these systems can help track seizure frequency and patterns over time, which may enhance clinical care, grant more independence, and support epilepsy research. Early evidence also suggests these technologies may reduce emergency healthcare utilization. 9
Device development in this space has rapidly expanded. Several Food and Drug Administration (FDA)–cleared seizure detection devices and platforms are now available, with growing performance and usability data, 10 though cost and reimbursement from insurance remain a significant barrier. 11 Emerging evidence supports promising performance, acceptance, and real-world impact.12-15 Surveys of patients and caregivers indicate increasing interest in these technologies to support independence, reduce caregiver anxiety, and promote rapid response when seizures occur, especially at night or when people with epilepsy are alone.16,17
Although the FDA has cleared noninvasive and approved invasive (implanted) seizure detection devices, this position statement focuses on noninvasive devices.
Joint Position
The American Epilepsy Society (AES), the Epilepsy Foundation (EF), and the Danny Did Foundation support the appropriate use of validated noninvasive SD/ADs as part of comprehensive epilepsy care and individualized safety planning. The sponsoring organizations also encourage third-party payors to cover these devices as medically necessary parts of the treatment of drug-resistant/refractory epilepsy.
These organizations emphasize:
Shared decision-making between clinicians, people with epilepsy, and caregivers Balanced counseling regarding benefits and limitations Affordable and equitable access to these technologies
These organizations do not endorse specific commercial products.
Clinical Use Cases
Noninvasive SD/ADs may offer meaningful clinical benefit in a variety of scenarios. For instance, for adults with epilepsy who have tonic–clonic (convulsive) seizures and are living alone, a wrist-worn device can alert family members in real time and provide objective seizure frequency data to inform treatment decisions. Parents of children with major motor seizures can also use nocturnal monitoring and alerting devices to facilitate safer sleep when they are not in the same room. Additionally, for individuals with suspected unwitnessed tonic-clonic (convulsive) seizures (eg, waking with sore muscles or tongue biting), clinicians may recommend SD/ADs to help objectively document when or how frequently such events occur.
Evidence Base
Across studies, noninvasive seizure detection devices demonstrate the strongest performance for detecting tonic-clonic (convulsive) seizures.13,18 Performance varies by device, sensing modality, study design, and setting, and should be interpreted using standardized metrics such as sensitivity, false alarm rate, and detection latency. Performance currently remains more limited for many seizure types, including focal impaired consciousness and absence seizures, among others. 19
Evidence is growing for effectiveness in home and community settings. A major benefit is real-time caregiver notification of detected seizures. These devices can also improve safety planning for individuals at elevated risk of seizure-related injury or harm and provide objective documentation of seizures to supplement self-reported diaries. 13 The use of devices has also been shown to reduce seizure-related anxiety and social burden, particularly among caregivers.11,20
Limitations
Current noninvasive SD/ADs have important limitations. Since many devices are optimized for tonic-clonic (convulsive) events, there can be incomplete or no detection of other nonconvulsive seizure types. False positives, which can erroneously alert caretakers when a detected signal is incorrectly identified as a seizure, can create issues, and contribute to alert fatigue. The rates of false positives may vary by device and individual factors, such as levels of alertness, wakefulness, or sleep stage changes, baseline heart rate and heart rate variability, or degree of physical activity and movement. For example, clinicians should note that device performance varies between sleep and wakefulness: while false alarm rates are lower during sleep, sensitivity across sleep stages remains incompletely characterized, as electrodermal activity is suppressed during deep NREM and muscle atonia during REM alters accelerometry baselines. 13 Additionally, there are several potential technical limitations that apply both to devices and users. Devices themselves can fail, can disconnect from Bluetooth or other communication pathways, and components can wear down over time. Users may not wear devices consistently, and children and individuals with developmental delay may find devices bothersome and remove them.
There is also insufficient data related to devices preventing SUDEP or other serious adverse outcomes. From a clinical standpoint, counseling should emphasize established risk reduction strategies, particularly for improving seizure control and reducing convulsive seizure frequency. Additionally, these limitations need to be weighed considering device cost, variable insurance coverage, and other access barriers can limit equitable use. Data generated by SA/SD devices and wearables must be protected with robust privacy and security safeguards. Patients should be informed about data ownership, secondary use, sharing practices, and risks. Optimal integration of the obtained data into clinical workflows must also be determined and implemented.
Clinical Practice Recommendations
AES, EF, and the Danny Did Foundation support the value of these practices for clinicians:
Regulatory and Ethical Considerations
AES, EF, and the Danny Did Foundation recognize the essential role of regulatory oversight in ensuring the safety and efficacy of medical devices and Software as a Medical Device. They support a clear differentiation between regulated medical devices and consumer wellness products (eg, general baby monitors or cameras not studied in epilepsy). They support ethical marketing and communication that avoid overstating capabilities or implying unproven benefits, such as SUDEP risk reduction. They support transparency regarding algorithm updates, changes in performance over time, and postmarket surveillance.
Clinicians should help patients and caregivers understand the distinction between regulated, epilepsy-specific devices and general consumer products that do not include epilepsy-focused evidence or FDA evaluation.
Ownership of data generated by seizure detection wearable devices beyond direct care remains legally ambiguous. Clear safeguards and transparent communication are needed to build trust and protect against unintended uses, such as insurers, employers, or disability adjudicators—representing a critical and unresolved patient rights issue that we must remain cognizant of and address over time.
Future Directions and Research Priorities
AES, EF, and the Danny Did Foundation acknowledge the potential of emerging technologies to advance epilepsy care, including multimodal sensing, machine learning, and closed-loop systems. Realizing this potential will require ongoing collaboration among clinicians, researchers, patients and caregivers, industry, regulators, and professional societies to ensure that innovation leads to safe, effective, and equitable improvements in the lives of people with epilepsy.
Priority areas for future research should include a focus on patient-centered outcomes.17,21 Examples include tracking the impact of effective device use on quality of life, sleep, caregiver burden, injury rates, emergency response and healthcare resource utilization, along with broader health economic and outcomes research. Improving the detection of, and ability to differentiate between, a broader range of seizure types will also be important, including improved differentiation from nonepileptic events. 22
For device studies, it will also be important to standardize outcome measures, reporting frameworks, and benchmarking methodologies to enable meaningful comparison across devices, different populations, and real-world settings. 19 The efficacy and accuracy of seizure detection and alerting wearables have not been adequately studied in people of color or racially and ethnically diverse populations, leaving significant gaps in our understanding of how these devices perform across all patients. For devices shown to be effective at seizure detection, additional studies are needed related to implementation, assessing adherence, human-factors considerations, alert fatigue, and optimal integration into clinician workflows. A key area of work will also need to focus on health equity and reimbursement, including coverage pathways, cost-effectiveness analyses, and strategies to reduce disparities in access and use. 14 Actively engaging people with epilepsy and caregivers throughout study design, technology development, usability testing, and evaluation, is critical for ensuring relevance and acceptability. 12
Key Messages Box
Clinician and Family Q&A on Noninvasive Epilepsy Monitoring Devices
What Seizure Types Are These Devices Best at Detecting?
Performance is strongest for tonic-clonic (convulsive) seizures and some motor seizures. Detection of many seizure types is still limited, and not all seizures will be captured, even with optimal device use.
Who Might Benefit Most From Using a Seizure Detection and Alerting Device?
People who may benefit include those who have tonic-clonic (convulsive) seizures and particularly those seizures that are nocturnal. This includes those who have suggestive signs of unwitnessed nocturnal convulsive seizures (eg, tongue biting, sore muscles on waking), people who live alone or have limited supervision and want a way to identify missed seizures or alert nearby caregivers. Seizure detection and alerting devices may also benefit families and caregivers who are concerned about missing seizures, and those who seek faster response and greater independence for the person with epilepsy.
What Are the Main Categories of Noninvasive Devices?
Common categories include wrist or limb wearables that use motion and physiologic signals (eg, accelerometry, electrodermal activity, surface EMG, heart-rate patterns), bed-based sensors, audio- and video-based systems (often used for nocturnal convulsive events), as well as EEG-based wearable devices.
What Benefits Can Families and Patients Realistically Expect?
Potential benefits include real-time alerts to caregivers when certain seizures occur, improved safety planning for individuals at higher risk of injury or harm, and more accurate seizure counts than may be provided by seizure diaries. Seizure detection and alerting devices may also reduce seizure-related anxiety and social burden for patients and caregivers. These benefits are most likely when device selection is appropriately matched to individual needs.
What Are the Main Limitations and Challenges of Seizure Detection and Alerting Devices?
An important limitation of SD/ADs is incomplete seizure detection. Current devices are not optimized to detect and seizures that are not tonic–clonic (convulsive) events. False alarms may also be anxiety-provoking, disruptive and lead to alert fatigue. Technical issues can also arise such as Bluetooth connectivity problems, battery life or charging requirements, and inconsistent wear. Tolerability can also be a concern, especially in children or individuals with developmental delay who may remove or not adhere to the use of wearable devices. There can be limitations with integrating device data into clinical workflows and unique data privacy and security concerns.
Are These Devices Proven to Prevent SUDEP?
There is currently insufficient evidence to demonstrate that devices prevent SUDEP. The value of seizure detection and alerting devices for SUDEP prevention is unproven. Counseling should be individualized, emphasizing established risk-reduction strategies such as improving seizure control and reducing tonic–clonic (convulsive) seizure frequency.
What Should Be Discussed When Selecting a Device?
When selecting a seizure-detecting and alerting device, clinicians, patients, and caregivers should consider goals with the specific seizure type in mind. Cost structure is an important consideration. Factors include comparison of a one-time payment to a subscription-based service as well as overall insurance coverage. It is also important to consider whether an existing device can be utilized for seizure-tracking purposes, such as a smartwatch that might support seizure detection apps.
Other considerations include the type of alerts generated and whether they can be paused or silenced. Discussion should include who may be the recipient of the alerts, how they would be incorporated into a seizure action plan and response. The individual, family and caregiver tolerance for false alarms and alert fatigue is a critical point that should be incorporated into discussions and decision-making. Privacy preferences should also be discussed, particularly with camera-based systems.
How Should Devices Be Incorporated into a Care Plan?
Shared decision-making should be used to identify which seizures the device is intended to detect, define a clear response plan for alerts, address privacy and data-sharing preferences, document the seizure action plan and instructions in the medical record. It is reasonable to reassess after a trial period to confirm that benefits outweigh burdens and adjust as needed.
What Is the Difference Between a Consumer Device and a Prescription or Epilepsy-Specific Device?
Consumer products (eg, generic baby monitors or cameras) are not designed or studied specifically for epilepsy and do not undergo the same regulatory review as medical devices. Epilepsy-specific devices and prescription products are evaluated for performance and safety in people with epilepsy and are subject to regulatory oversight.
How Does Insurance Coverage Work for These Devices?
Coverage is variable across payers and programs. When pursuing coverage, clinicians can document seizure type and relevant risks (eg, injury history, nocturnal tonic-clonic/convulsive seizures), describe the caregiver plan and how alerts will be used, and explain why detection or alerting is medically necessary for safety and health outcomes.
Where Can Clinicians and Families Find up-to-Date, Nonpromotional Information?
Patient-education and advocacy organizations often maintain regularly updated device overviews and selection guidance. AES, EF, and The Danny Did Foundation do not endorse specific commercial products but encourage use of reputable educational resources, including The Danny Did Foundation (https://www.dannydid.org/) for current device landscapes and decision aids.
Footnotes
Author Contributions
All authors reviewed and approved the final manuscript.
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Disclosures and Ethical Publications
No technology or device company contributed to or reviewed this manuscript at any stage of development. The organizations and authors do not endorse specific commercial products. All authors reviewed and approved the final manuscript, and no other disclosures relevant to this manuscript were reported.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
