NCT06210022Recruiting
Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy
Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy: a Longitudinal Observational Study
Source: ClinicalTrials.gov · Last updated 24 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 130 (estimated)
- First submitted
- 21 Dec 2023
- Start date
- 20 Jun 2024
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Epilepsy
- NCT number
- NCT06210022
What you commit to
- Study type: Observational
- Planned participants: 130
- From 20 Jun 2024 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- alcohol and/or psychotropic drugs abuse
Other illness
- 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;
Age
- Age\> 60 years;
Other
- Documented developmental delay;
- Evidence of focal abnormalities at neuroimaging (except of hippocampal sclerosis);
Who the study is looking for
- 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)
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.