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

Launched by IRCCS SAN RAFFAELE · Jan 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how cognitive abilities are affected in people with focal cryptogenic epilepsy, specifically comparing those who have drug-resistant epilepsy (DRE) with those whose epilepsy is controlled by medication (DSE). The researchers want to understand how different patterns in brain activity, measured through a special type of brain scan called EEG, relate to cognitive performance and behavior over time. Participants will undergo clinical and cognitive assessments, and those with DRE will have follow-up assessments at 6 and 12 months to monitor any changes.

To be eligible for the trial, participants must be Italian speakers between the ages of 18 and 60, have a diagnosis of focal cryptogenic epilepsy, and meet specific criteria related to their treatment history and seizure control. For instance, those with DRE must have tried at least two anti-seizure medications without success, while those with DSE must have achieved seizure control with no more than two medications. Participants can expect to take part in various assessments during the study, contributing to a better understanding of the relationship between epilepsy and cognitive function. Importantly, the study is focused on gathering information in a safe and supportive environment, and participation will help enhance future treatment approaches for epilepsy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Inclusion criteria for all study subjects:
• • monolingual native Italian speakers;
• • age between 18-60 years;
• • normal or corrected-to-normal visual acuity;
• • oral and written informed consent to study participation.
• • if assuming psychotropic drugs (i.e., benzodiazepines, antipsychotics, antidepressants), they should be at stable dosage for more than 4 weeks.
• * Inclusion criteria for DRE patients:
• • diagnosis of focal cryptogenic epilepsy;
• • previous failure of at least 2 anti-seizure medication (ASM at adequate dose;
• • at least 3 seizures in the last 2 months; • available brain MRI (\<5 years).
• * Inclusion criteria for DSE patients:
• • diagnosis of focal cryptogenic epilepsy;
• • seizure control obtained after not more than 2 ASM;
• • seizure freedom for at least 6 months;
• • available brain MRI (\<5 years).
• * Inclusion criteria for NDE patients:
• • new diagnosis of focal cryptogenic epilepsy (\<3 months)
• • not more than 1 ASM tested
• • available brain MRI (\<3 months)
• Exclusion Criteria:
• • Age\> 60 years;
• • Documented developmental delay;
• • Evidence of focal abnormalities at neuroimaging (except of hippocampal sclerosis);
• • Neurological degenerative conditions;
• • history of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic, psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations;
• • alcohol and/or psychotropic drugs abuse