Multicenter clinical trial explores a new era of long-term epilepsy monitoring with sub-scalp EEG technology

Epileptic seizures are unpredictable, often occurring in clusters followed by seizure-free periods lasting weeks or months. Diagnosing and characterizing epilepsy depends on capturing these sporadic seizures during electroencephalography (EEG) monitoring. Traditional EEG studies, lasting hours to days, may miss these events, while prolonged in-hospital monitoring can be inconvenient and disruptive for patients.

Duke is participating in DETECT, a multicenter clinical trial investigating whether long-term, continuous EEG monitoring device can improve clinical decision-making for people with epilepsy.

“One of the biggest limitations in epilepsy care is that we often rely on a brief snapshot of brain activity to understand a condition that evolves over time,” says Shruti Agashe, MD, MS, assistant professor of neurology and principal investigator for Duke's DETECT study. Agashe specializes in surgical epilepsy, neuromodulation, and technologies that use brain signals to guide personalized care. “By extending brain monitoring from hours or days to months, we have the potential to fundamentally change how we capture, characterize, and understand seizures and their patterns over time.”

The study evaluates the Minder system that consists of a thin wire placed under the scalp, with four contacts that record brain activity from both sides of the head. A small implantable component behind the ear wirelessly transmits brain activity to an external wearable, which transfers the recordings through a smartphone application for local storage and physician review. Unlike conventional external EEG recording systems, this technology enables prolonged monitoring over months while patients continue their everyday activities.

Derek Southwell, MD, PhD, associate professor of neurosurgery and surgical director of the Duke Comprehensive Epilepsy Center, has been implanting the Minder device into patients enrolled in the clinical trial. “Placement of the internal device is a straightforward surgical procedure with relatively minimal risk,” he said. “As the device is placed under the scalp, implantation can be completed in less than an hour, and patients do not require hospitalization following surgery. Once monitoring is complete, the device can then be surgically removed without difficulty.”

Patient-reported seizures, as gathered in seizure diaries, are an important part of diagnosis and monitoring, but they may not accurately reflect the true frequency or nature of seizure events. For example, subtle seizures, nocturnal seizures, unwitnessed seizures, or seizures associated with amnesia may go unrecognized or unreported. Also, some patient-reported events may not be epileptic seizures. Continuous EEG monitoring could aid seizure identification and reporting by providing objective measures of brain activity.

“When we don't have an accurate picture of how often seizures occur, it can be difficult to determine whether a treatment is truly working,” Agashe explains. “Having more objective

information about seizure frequency could help physicians make better-informed decisions about medications and other therapies.”

The research study examines whether access to continuous EEG information can improve clinical decision-making for patients with epilepsy. The multicenter study plans to enroll up to 210 participants across the United States.

As a Level 4 epilepsy center, Duke provides advanced evaluation and treatment for patients with complex epilepsy. Its expertise in comprehensive epilepsy care, intracranial EEG monitoring, surgical epilepsy, and emerging neurotechnologies positions Duke to contribute to the trial and the development of new approaches to long-term epilepsy management.

“We are only beginning to understand what continuous recordings of brain activity could teach us,” Agashe says. “The real opportunity is to move beyond simply documenting seizures toward understanding the underlying brain dynamics that influence when and why seizures occur. Over time, these insights could help us anticipate changes in seizure risk and ultimately develop treatments that are more responsive to each patient's individual epilepsy.”

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