Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy
Recruiting · NCT06210022 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS San Raffaele
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a national monocentric (San Raffaele Hospital - OSR, Via Olgettina, 60, 20132 Milan, Italy) observational low-risk-intervention study, prospective and multiparametric (clinical, EEG, neuropsychological evaluations) study. Patients with a diagnosis of DRE and DSE will be screened to evaluate their eligibility. They will undergo clinical and cognitive assessments in addition to 32channel EEG at baseline (T0). DRE patients will also undergo clinical and cognitive assessments, and 32-channel EEG at 6 months (T1), and 12 months (T2). Patients newly diagnosed with focal cryptogenic epilepsy (NDE) will undergo clinical and cognitive assessments, and 32-channel EEG at baseline (T0), at 6 months (T1), and 12 months (T2). High-definition EEG will be performed to investigate patterns of cortical sources and functional connectivity alteration specific to DRE and DSE and to explore their prognostic value. Longitudinal EEGs will be acquired to explore the evolution of EEG patterns. Cognitive evaluation will be performed by an experienced neuropsychologist. At baseline, DRE, DSE, and NDE patients will undergo a screening and a comprehensive cognitive battery in order to define performance differences among groups. The DRE and NDE group only will perform the same neuropsychological assessment at month 6 and 12 for monitoring the potential progression of cognitive and/or behavioural disturbances in these patients.
Who can take part
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 is running
1 location listed.
- IRCCS San Raffaele - Milan, Italy