Actively Recruiting
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
Eligibility Criteria
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)
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
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
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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