Seer Home and Ambulatory Video-EEG-ECG for the Diagnosis of Seizure Disorders

The Seer Home system is a group of combined technologies that deliver home video-electroencephalography-electrocardiography (EEG-ECG) monitoring for up to one week in patients four years and older.¹ The device (Seer Sense) is worn around the shoulders and has gel-adhesive electrodes that connect to the patient's head and chest. Video footage is recorded, and EEG-ECG data are wirelessly transmitted to a monitoring hub where an artificial intelligence–enabled review platform synthesizes information but does not draw diagnostic conclusions. A technician monitors and reviews the data, and the patient's physician can access a web portal with full data. The U.S. Food and Drug Administration has granted this device 510(k) clearance.²

Clinical testing is not required when a medical device receives traditional 510(k) clearance. The indications for use are compared with similar devices previously on the market. In this case, the Seer Home system was compared with the MobileMedTek Electro Tek. Ambulatory EEG systems with proven safety and effectiveness have been on the market for many years.²

When inpatient video-EEG was compared with ambulatory video-EEG, no significant difference was seen in diagnostic yield.³ However, well-powered studies are limited, and results are influenced by pretest probability, leading to a large range in diagnostic yield or capturing one event on video. In previous studies, diagnostic yield ranged from 24.9% to 85% for ambulatory video-EEG because of the variability of pretest probability in the patient populations.⁴

A prospective study compared 41 patients monitored via ambulatory video-EEG with 64 patients monitored via inpatient video-EEG. Both groups were monitored for 48 hours.⁵ Patients were recruited by neurologist referral, and the study was not randomized because patients had to be suitable for home investigation. The study found comparable diagnostic effectiveness (measured by the number of seizure events recorded) between the two groups. When evaluating between epileptic and nonepileptic events, the diagnostic question (when a patient was referred to discern between epileptic vs. nonepileptic seizures) was answered in 67% of ambulatory video-EEGs and 63% of inpatient video-EEGs.

In an unpublished retrospective review including 6,265 patients (45% with events), higher rates of events were captured with the Seer Home system compared with ambulatory EEG products (94% vs. 80%, respectively). This was due to significant improvements in video technology, including wide-angle view and automatic transition to low-light infrared recording.⁶

Ambulatory video-EEG monitoring systems are useful diagnostic tools because monitoring outside of the patient's home can artificially affect the results.¹ Additionally, ambulatory video-EEG has been helpful in capturing interictal epileptiform discharges before initiating antiepileptic drugs, ending the use of these drugs in seizure-free patients; classifying epilepsy syndromes; and quantifying seizure burden to guide antiepileptic drug therapy.⁷

The manufacturer of the Seer Home system advertises a supplemental proprietary digital application that tracks potential epileptiform activity with the goal of generating a “forecast” for future seizure events. Forecasting depends on the theory of cyclic rhythms in seizure activity. By using patient-reported event data, the Seer app can categorize periods of time as low, medium, and high risk of seizure in the next hour.⁸ This may help alleviate the psychosocial burden and potential safety concerns caused by the uncertainty of seizure occurrences, especially for the 30% of patients with epilepsy who are refractory to antiepileptic drugs.