Evaluating cognitive impairment in patients with focal cryptogenic epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess cognitive impairment in patients with drug-resistant epilepsy (DRE), drug-sensitive epilepsy (DSE), and newly diagnosed epilepsy (NDE) through clinical evaluations, neuropsychological assessments, and high-density EEG recordings. Participants will undergo evaluations at baseline and follow-up periods of 6 and 12 months for DRE and NDE patients, while DSE patients will only be assessed at baseline. The study will investigate the relationship between cognitive function and EEG patterns to understand the prognostic value of these assessments in epilepsy management.

Why it matters

Who can join: the full rules

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

Where it's running

• IRCCS San Raffaele
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Anna Bellini, MD
• Email: bellini.anna@hsr.it
• Phone: +390226432154

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.