Home monitoring of seizures using a wearable EEG device for rare epilepsies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• S.S.D. Neurofisiologia Clinica - AOU di Modena
  Modena, Taly, Italy Recruiting
• Ospedale pediatrico Bambino Gesù
  Roma, Italy, Italy Not yet recruiting
• Azienda Sanitaria Universitaria Giuliano Isontina
  Trieste, Italy, Italy Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.