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RECRUITING
NCT06210022

Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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, 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.

Official title: Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy: a Longitudinal Observational Study

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

130

Start Date

2024-06-20

Completion Date

2027-03-01

Last Updated

2024-06-24

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Neuropsychological Assessment

Cognitive evaluation and clinical monitoring of seizure frequency

Locations (1)

IRCCS San Raffaele

Milan, Italy