Brief Summary

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.

Conditions

• Epilepsies
• Epilepsies, Focal
• Epileptic Encephalopathy

Intervention / Treatment

• Device: Ultra-longterm EEG monitoring at home by means of a scubscalp electrode implant.

Primary Outcome Measures

• Assessment of the reportability (12-24 weeks from device activation)
  The results (i.e., number of seizures, date and time) will be matched with the subject's seizure diary to look for concordance.

Countries

Italy

Locations and Investigators

• S.S.D. Neurofisiologia Clinica - AOU di Modena, Modena, Italy (Recruiting)
  • Stefano Meletti, MD, PhD
  • Stefania Maffei, PhD
• Azienda Ospedaliero Universitaria Federico II - Napoli, Napoli, Italy (Not yet recruiting)
  • Antonietta Coppola, MD, PhD
• Ospedale pediatrico Bambino Gesù, Roma, Italy (Not yet recruiting)
  • Nicola Specchio, MD, PhD
• Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy (Not yet recruiting)
  • Paolo Manganotti, MD, PhD

Study Officials

• Stefano Meletti, MD, PhD (Principal Investigator) — Azienda Ospedaliero Universitaria di Modena - Ospedale Civile di Baggiovara - S.S.D. Neurofisiologia