Sample size
PFO, cryptogenic stroke, migraine, seizure
MIGRAINE
In our previous study, we conducted PFO closure in 28 cases of PRE accompanied by PFO in high-grade RLS and examined the seizure frequency of patients between one-year prior to surgery and one-year thereafter. We found that patients had an average decrease of 49.60% in seizure frequency one year after surgery compared to that before surgery, with a standard deviation of 41.67%.Referring to the parameter settings in the studies on PFO closure in the treatment of cryptogenic stroke or migraine, the treatment regimen in the control group of this trial is consistent with that in the above studies. Therefore, we estimated that the average decrease in seizure frequency in the intervention group was 50%, with a standard deviation of 0.42; and an average decrease in the control group of 20%, with a standard deviation of 0.20. Combined with a superiority margin of 0.1, a single-sided alpha of 0.025, and a test power of 0.80, the total sample size required is 88. To account for possible participant withdrawal and loss to follow-up, we increase the sample size by 20%. Therefore, we shall recruit 110 subjects for this study [