Seizure detection devices for use in antiseizure medication clinical trials: A systematic review

Abstract Objective This study characterizes the current capabilities of seizure detection device (SDD) technology and evaluates the fitness of these devices for use in anti-seizure medication (ASM) clinical trials. Methods Through a systematic literature review, 36 wireless SDDs featured in published device validation studies were identified. Each device’s seizure detection capabilities that addressed ASM clinical trial primary endpoint measurement needs were cataloged. Results The two most common types of seizures targeted by ASMs in clinical trials are generalized tonic-clonic (GTC) seizures and focal with impaired awareness (FIA) seizures. The Brain Sentinel SPEAC achieved the highest performance for the detection of GTC seizures (F 1 -score = 0.95). A non-commercial wireless EEG device achieved the highest performance for the detection of FIA seizures (F 1 -score = 0.88). Discussion A preliminary assessment of device capabilities for measuring selected ASM clinical trial secondary endpoints was performed. The need to address key limitations in validation studies is highlighted in order to support future assessments of SDD fitness for ASM clinical trial use. In tandem, a stepwise framework to streamline device testing is put forth. These suggestions provide a starting point for establishing SDD reporting requirements before device integration into ASM clinical trials.