Actively Recruiting
Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy: a Longitudinal Observational Study
Led by IRCCS San Raffaele · Updated on 2024-06-24
130
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating cognitive impairment in patients with focal cryptogenic epilepsy, specifically comparing those with drug-resistant epilepsy (DRE) and drug-sensitive epilepsy (DSE). The study is a national, single-center, observational investigation conducted at San Raffaele Hospital in Milan, Italy. It aims to explore cognitive performance differences, EEG patterns, and the relationship between seizure frequency, anti-seizure medication (ASM) therapy, and cognitive impairment. Participants include groups of patients diagnosed with DRE, DSE, and newly diagnosed epilepsy (NDE). All groups undergo clinical and cognitive assessments alongside 32-channel EEG at baseline. DRE and NDE patients also receive follow-up assessments and EEG at 6 months and 12 months, while DSE patients are assessed only at baseline. EEGs will be used to study cortical sources and functional connectivity changes, with vigilance monitored during recordings. Cognitive testing covers multiple domains, and quality of life is measured using the SF-12 survey. During the study, participants will have neuropsychological evaluations performed by experienced neuropsychologists, and clinical data including seizure frequency and ASM therapy will be recorded. EEG data will be stored digitally for analysis. The primary outcomes focus on the prevalence and progression of cognitive impairment, seizure frequency impact, and EEG markers in these patients over a three-year period. The study involves longitudinal monitoring for up to one year for most groups to observe changes in cognition and drug responsiveness.
CONDITIONS
Brief Title
Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Native Italian speaker who speaks only Italian
- Age between 18 and 60 years
- Normal or corrected-to-normal vision
- Provided oral and written informed consent to participate
- Stable dosage of any psychotropic drugs for more than 4 weeks if used
- Diagnosis of focal cryptogenic epilepsy for DRE patients
- Failure of at least 2 anti-seizure medications at adequate doses for DRE patients
- At least 3 seizures in the last 2 months for DRE patients
- Available brain MRI within the last 5 years for DRE patients
- Diagnosis of focal cryptogenic epilepsy for DSE patients
- Seizure control after no more than 2 anti-seizure medications for DSE patients
- Seizure freedom for at least 6 months for DSE patients
- Available brain MRI within the last 5 years for DSE patients
- New diagnosis of focal cryptogenic epilepsy within the last 3 months for NDE patients
- Not more than 1 anti-seizure medication tried for NDE patients
- Available brain MRI within the last 3 months for NDE patients
You will not qualify if you...
- Age over 60 years
- Documented developmental delay
- Focal abnormalities on neuroimaging except hippocampal sclerosis
- Neurological degenerative diseases
- History of systemic diseases including recent cancers and abnormal liver or kidney function
- History of neurological, psychiatric diseases, head injury, cardiovascular or cerebrovascular events
- Alcohol or psychotropic drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline (study entry)
Participants undergo cognitive evaluations, neurological examinations, and 32-channel EEG to assess cognitive domains, seizure frequency, and brain activity.
1 baseline visit (in-person)
Duration - 12 months
Participants with drug-resistant and newly diagnosed epilepsy undergo repeated cognitive, clinical, and EEG evaluations at 6 and 12 months to monitor changes over time.
2 follow-up visits (in-person) at 6 and 12 months
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele
Milan, Italy, 20132
Actively Recruiting
Research Team
A
Anna Bellini, MD
D
Davide Gusmeo Curti, MD
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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