Home monitoring of seizures using a wearable EEG device for rare epilepsies
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
This study is testing a new wearable device that helps people with rare types of epilepsy monitor their seizures at home to see if it can improve their treatment and care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria di Modena Academic / other |
| Locations | 4 sites (Roma, Italy and 3 other locations) |
| Trial ID | NCT06855901 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a patient-centered care model through home ultra-long-term EEG monitoring using a minimally invasive wearable device. It will assess the sensitivity, reliability, and safety of the device in recording seizures over extended periods, while also evaluating automated seizure detection algorithms. The goal is to improve clinical management and treatment outcomes for patients with drug-resistant seizures, developmental and epileptic encephalopathies. Participants will be monitored for up to 24 weeks to quantify seizure frequency and inform personalized treatment plans.
Who should consider this trial
Good fit: Ideal candidates include individuals over 12 years old with drug-resistant seizures, developmental and epileptic encephalopathies, or rare epilepsies.
Not a fit: Patients with psychiatric disorders or those at high risk for surgical complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective management and treatment of seizures in patients with rare epilepsies.
How similar studies have performed: Other studies have shown promise with similar wearable EEG monitoring approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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); Exclusion Criteria: * Subjects with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder; * Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement; * Subject has an infection at implant site; * Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease; * Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant (cochlear implant(s)); * Subject has a profession or hobby that includes activity imposing an unacceptable risk for trauma to the device or implant site, e.g. martial arts or boxing; * Subject has a contraindication to the use of local anesthetic drugs used during implantation- and removal of the device; * Subject is unable or does not have the necessary assistance to properly operate the device system. * Pregnancy
Where this trial is running
Roma, Italy and 3 other locations
- Ospedale pediatrico Bambino Gesù — Roma, Italy, Italy (Not_yet_recruiting)
- Azienda Sanitaria Universitaria Giuliano Isontina — Trieste, Italy, Italy (Not_yet_recruiting)
- S.S.D. Neurofisiologia Clinica - AOU di Modena — Modena, Taly, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Federico II - Napoli — Naples, Taly, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Stefano Meletti, MD, PhD — Azienda Ospedaliero Universitaria di Modena - Ospedale Civile di Baggiovara - S.S.D. Neurofisiologia
- Study coordinator: Stefania Maffei, PhD
- Email: maffei.stefania@aou.mo.it
- Phone: +390593961157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.