Digital biomarkers and ambulatory seizure detection in epilepsy clinical trials
Summary
This review examines the development and validation of digital biomarkers using wearable devices and implantable systems for ambulatory seizure detection in epilepsy clinical trials. The paper discusses technical approaches including accelerometry, electrodermal activity, heart rate variability, and invasive EEG monitoring, along with regulatory considerations for digital endpoints in drug development.
Why it matters
Traditional seizure diaries are subjective and often inaccurate. Digital biomarkers offer objective, continuous seizure monitoring that can transform epilepsy clinical trials by providing more reliable endpoints. This review provides a roadmap for integrating wearable and implantable sensors into drug development programs, potentially accelerating the evaluation of new anti-seizure therapies.
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