With this study the Investigator expects to develop a precise patient-centered model of care by means of home ultra-long-term EEG monitoring with a minimally invasive wearable EEG device (sqEEG).
The following aims will be pursued:
1. to assess the sensitivity, reliability, and safety of sqEEG to record seizures over prolonged periods; 2. to verify sensitivity and reliability of automated seizure detection algorithms and to assess circadian and ultradian seizure/interictal epileptic discharges; distribution for the development of personalized seizure action plan; 3. to evaluate whether data collected with sqEEG can improve the clinical management of the patients and treatment outcomes.
The investigator expects to use this wearable at-home EEG device to obtain an objective quantification of electrographic and electro-clinical seizures over a twelve-week period up to twenty-four weeks at home. The precise quantification of seizures is essential for a tailored treatment approach and to effectively monitor the response to treatment adjustments.
The potential innovation of this approach relies on the possibility of managing the patient at home, reducing the side effects related to hospitalization and objectively quantifying the disease burden in the real-life setting with the aim of improve globally the patients' quality of life.
Age > 12 years old, with or without intellectual disabilities;
Diagnosis of drug resistant seizures, DEE or rare epilepsies ;
One or more seizure types as established by previous epilepsy history thus allowing to define seizure type and scalp topography of the ictal discharge;
Availability for the duration of the study (3 months);
Subjects with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder;
Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement;
Subject has an infection at implant site;
Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease;
Azienda Ospedaliero-Universitaria di Modena
Lead sponsor
Azienda Ospedaliera Universitaria Federico II (AOU Federico II)
Collaborator
Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy
Collaborator
Ospedale Pediatrico Bambino Gesù, Rome (IT)
Collaborator