How many patients do you need? A trial-design simulation for anti-seizure treatment in acute brain injury
Year: 2026
Type: software
Abstract: **Objective.** Designing randomized trials of anti-seizure treatment in critically ill patients is hard because seizure burden and drug response are highly heterogeneous. We built a simulation framework to estimate how many patients a trial would need under various designs. **Methods.** Using continuous-EEG and medication data from a subarachnoid- hemorrhage cohort, we fit patient-level log-normal models of seizure/spike dynamics and drug response, then simulated randomized trials to compute required sample sizes and detectable effect sizes for outcomes such as complete seizure cessation, across treatment-delay and drug-response scenarios. **Results.** The framework quantifies the sample size and effect size needed under each design, showing how trial feasibility depends on the outcome definition and response assumptions. This project releases the de-identified patient-level parameters and time series and the simulation code.
Source: Brain Data Science Platform
DOI: 10.60508/qtgg-4b48
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W7168014560