Actively Recruiting
Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy
Led by IRCCS San Raffaele · Updated on 2024-06-24
130
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be a monolingual native Italian speaker
- Be aged between 18 and 60 years
- Have normal or corrected-to-normal vision
- Provide oral and written informed consent to participate
- If taking psychotropic drugs (benzodiazepines, antipsychotics, antidepressants), be on a stable dose for more than 4 weeks
- For DRE patients: have a diagnosis of focal cryptogenic epilepsy
- For DRE patients: have failed at least 2 anti-seizure medications at adequate doses
- For DRE patients: have had at least 3 seizures in the last 2 months
- For DRE patients: have a brain MRI within the last 5 years
- For DSE patients: have a diagnosis of focal cryptogenic epilepsy
- For DSE patients: have seizure control after no more than 2 anti-seizure medications
- For DSE patients: have been seizure free for at least 6 months
- For DSE patients: have a brain MRI within the last 5 years
- For NDE patients: have a new diagnosis of focal cryptogenic epilepsy within the last 3 months
- For NDE patients: have tested no more than 1 anti-seizure medication
- For NDE patients: have a brain MRI within the last 3 months
You will not qualify if you...
- Be older than 60 years
- Have documented developmental delay
- Have focal abnormalities on neuroimaging (except hippocampal sclerosis)
- Have neurological degenerative conditions
- Have history of systemic diseases, neurologic or psychiatric diseases, head injury, cardiovascular events, or cerebrovascular issues
- Have alcohol or psychotropic drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele
Milan, Italy, 20132
Actively Recruiting
Research Team
A
Anna Bellini, MD
CONTACT
D
Davide Gusmeo Curti, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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