Status:
RECRUITING
Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Epilepsy
Focal Epilepsy
Eligibility:
All Genders
18-60 years
Brief Summary
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, neuropsyc...
Detailed Description
At the study entry (T0) DSE, DRE, and NDE will undergo cognitive evaluations (investigating the main cognitive domains), neurological examinations, and 32channel EEG. DRE and NDE patients will undergo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06210022
Start Date
June 20 2024
End Date
March 1 2027
Last Update
June 24 2024
Active Locations (1)
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1
IRCCS San Raffaele
Milan, Italy, 20132