Long-term Study of Cognitive Changes in Adults with Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy

What this Trial Is About

Researchers are evaluating cognitive impairment in patients with focal cryptogenic epilepsy, specifically comparing those with drug-resistant epilepsy DRE and drug-sensitive epilepsy DSE. The study is a national, single-center, observational investigation conducted at San Raffaele Hospital in Milan, Italy. It aims to explore cognitive performance differences, EEG patterns, and the relationship between seizure frequency, anti-seizure medication ASM therapy, and cognitive impairment. Participants include groups of patients diagnosed with DRE, DSE, and newly diagnosed epilepsy NDE. All groups undergo clinical and cognitive assessments alongside 32-channel EEG at baseline. DRE and NDE patients also receive follow-up assessments and EEG at 6 months and 12 months, while DSE patients are assessed only at baseline. EEGs will be used to study cortical sources and functional connectivity changes, with vigilance monitored during recordings. Cognitive testing covers multiple domains, and quality of life is measured using the SF-12 survey. During the study, participants will have neuropsychological evaluations performed by experienced neuropsychologists, and clinical data including seizure frequency and ASM therapy will be recorded. EEG data will be stored digitally for analysis. The primary outcomes focus on the prevalence and progression of cognitive impairment, seizure frequency impact, and EEG markers in these patients over a three-year period. The study involves longitudinal monitoring for up to one year for most groups to observe changes in cognition and drug responsiveness.

Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy