Home Ultra-longterm EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies. an Open Label Nonpharmacological Interventional Prospective Study by Means of Minimally Invasive Wearable EEG Device

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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);

Locations
Other Locations
Italy
S.S.D. Neurofisiologia Clinica - AOU di Modena
RECRUITING
Modena
Azienda Ospedaliero Universitaria Federico II - Napoli
NOT_YET_RECRUITING
Napoli
Ospedale pediatrico Bambino Gesù
NOT_YET_RECRUITING
Roma
Azienda Sanitaria Universitaria Giuliano Isontina
NOT_YET_RECRUITING
Trieste
Contact Information
Primary
Stefania Maffei, PhD
maffei.stefania@aou.mo.it
+390593961157
Time Frame
Start Date: 2024-01-17
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 30
Treatments
Experimental: Experimental Group
Patients with drug-resistant epilepsies. Age \> 12 years
Related Therapeutic Areas
Sponsors
Collaborators: Ospedale Pediatrico Bambino Gesù, Rome (IT), Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy, Azienda Ospedaliera Universitaria Federico II (AOU Federico II)
Leads: Azienda Ospedaliero-Universitaria di Modena

This content was sourced from clinicaltrials.gov