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;
Single group
Ultra-longterm EEG monitoring at home by means of a scubscalp electrode implant.
DeviceSubjects with uncontrolled seizures previously investigated in outpatients epilepsy clinics and for whom an admission to the Epilepsy Monitoring Unit is indicated by clinical practice, will be screened for eligibility. Implantation of subcutaneous EEG electrodes will be done at each Research Unit by a neurosurgeon/surgeon. The implantation procedure will consist of placing subcutaneously the electrode contacts over the site of the suspected seizure focus as defined by a previous Video-EEG and neuroimaging evaluations. Surgical procedures will be performed under local anesthesia. If the device is well-tolerated, all the subjects will proceed to the extended home monitoring study, which is the core of the study protocol. The aim of the extended study is to assess sensitivity of seizure detection of sqEEG in comparison to subject's home diary, and the tolerability and safety of sqEEG in a period of 6 months.
Assessment of the reportability
The results (i.e., number of seizures, date and time) will be matched with the subject's seizure diary to look for concordance.
Assessment of Device-Related Adverse Events:
Will be collected from the subject during the study visits and by means of a specific form. The presence of the following side-effects will be checked: formation of haematoma or seroma near the implant site; temporary pain, headache, infection and discomfort; skin ischemia potentially inducing necrosis at the implant site due to pressure and compromised local circulation; Infection, swelling, soreness, irritation or itching of the skin at the implant site; occasional headache or pain during long-term use of the device.
Evaluation of the algorithm for automatic seizure detection (ASD)
The sqEEG data will be analyzed by the ASD algorithm; the results of the ASD algorithm will be reviewed by investigators blinded from the results of the visual analysis.
Assessment of potential clinical impact
The results of the 3-month sqEEG monitoring will be evaluated in terms of their possible impact on patient's clinical management
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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
