Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies

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

Interventions

DEVICE

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

Subjects 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Federico II (AOU Federico II)

  collaborator UNKNOWN

• Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy

  collaborator UNKNOWN

• Ospedale Pediatrico Bambino Gesù, Rome (IT)

  collaborator UNKNOWN

• Azienda Ospedaliero-Universitaria di Modena

  lead OTHER

Principal Investigators

• Stefano Meletti, MD, PhD · Azienda Ospedaliero Universitaria di Modena - Ospedale Civile di Baggiovara - S.S.D. Neurofisiologia

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-17

Primary Completion

2026-05-31

Completion

2026-12-30

Countries

• Italy

Study Locations