Actively Recruiting

Phase Not Applicable
Age: 12Years +
All Genders
NCT06855901

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

Led by Azienda Ospedaliero-Universitaria di Modena · Updated on 2025-03-04

30

Participants Needed

4

Research Sites

154 weeks

Total Duration

On this page

Sponsors

A

Azienda Ospedaliero-Universitaria di Modena

Lead Sponsor

A

Azienda Ospedaliera Universitaria Federico II (AOU Federico II)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 12 years old, with or without intellectual disabilities
  • Diagnosis of drug resistant seizures, developmental and epileptic encephalopathy, or rare epilepsies
  • One or more seizure types established by previous epilepsy history allowing definition of seizure type and scalp topography
  • Availability to participate for the duration of the study (3 months)
Not Eligible

You will not qualify if you...

  • Psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder
  • Skeletal deformities or damage at implantation site impeding correct electrode placement
  • Infection at the implant site
  • High risk of surgical complications such as active systemic infection or hemorrhagic disease
  • Presence of medical devices delivering electrical energy near the implant (e.g., cochlear implants)
  • Profession or hobby with high risk of trauma to the device or implant site (e.g., martial arts, boxing)
  • Contraindication to local anesthetic drugs used during implantation or removal
  • Inability or lack of necessary assistance to properly operate the device system
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Ospedale pediatrico Bambino Gesù

Roma, Italy, Italy, 00165

Not Yet Recruiting

2

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, Italy, Italy, 34128

Not Yet Recruiting

3

S.S.D. Neurofisiologia Clinica - AOU di Modena

Modena, Taly, Italy, 41126

Actively Recruiting

4

Azienda Ospedaliero Universitaria Federico II - Napoli

Naples, Taly, Italy, 80131

Not Yet Recruiting

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Research Team

S

Stefania Maffei, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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