Evaluating cognitive impairment in patients with focal cryptogenic epilepsy
Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy: a Longitudinal Observational Study
This study is testing how epilepsy affects thinking skills in people with different types of epilepsy to see if brain activity patterns can help understand their cognitive challenges better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06210022 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include Italian-speaking adults aged 18-60 with focal cryptogenic epilepsy, either drug-resistant, drug-sensitive, or newly diagnosed.
Not a fit: Patients with epilepsy types other than focal cryptogenic epilepsy or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of cognitive impairment in epilepsy, leading to improved patient management and treatment strategies.
How similar studies have performed: While there have been studies on cognitive impairment in epilepsy, this specific approach focusing on DRE, DSE, and NDE with high-density EEG is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- IRCCS San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Anna Bellini, MD
- Email: bellini.anna@hsr.it
- Phone: +390226432154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.