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

Launched by AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor seizures at home using a special wearable device called a sqEEG. This device allows doctors to record brain activity and seizures over a long period, up to six months, without needing to stay in the hospital. The goal is to gather detailed information about each patient's seizures to create personalized treatment plans that can improve their quality of life. The researchers want to find out how well the device works, how safe it is, and whether it can help doctors manage patients' conditions better.

To participate in the study, individuals need to be over 12 years old and have a diagnosis of drug-resistant seizures or specific types of rare epilepsy. They should also be able to commit to the study for about three months. Participants will wear the device at home while their brain activity is recorded, which helps doctors understand their seizures more clearly. It’s important to note that people with certain medical conditions, like severe psychiatric disorders or infections, may not be eligible to join. Overall, this trial aims to make managing epilepsy easier and improve the lives of those affected.

Gender

ALL

Eligibility 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