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

•Seizure detection devices may be useful for reporting ASM trial primary endpoints.•The highest performing devices are SPEAC (GTCs) and a wireless EEG device (FIAs).•Some devices are also capable of reporting secondary endpoints in ASM trials.•Recommendations are put forth to address limitations in device validation studies.•A framework is suggested to streamline testing before device use in ASM trials. 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. 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. 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 (F1-score = 0.95). A non-commercial wireless EEG device achieved the highest performance for the detection of FIA seizures (F1-score = 0.88). 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.