Home EEG monitoring for rare epilepsies and developmental epileptic encephalopathies
Tests a wearable home brain-wave device to track seizures in people with rare epilepsies.
Plain-language title generated from the registry record
Registry title: Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies
Key facts
- Where
- Modena, Naples, Roma, and Trieste, ItalySee the 4 sites
Where in Italy
- S.S.D. Neurofisiologia Clinica - AOU di ModenaModena, ItalyTaking people
- Azienda Ospedaliero Universitaria Federico II - NapoliNaples, ItalyNot yet recruiting
- Ospedale Pediatrico Bambino GesùRoma, ItalyNot yet recruiting
- Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Ospedaliero-Universitaria di Modena
- Trial code
- NCT06855901
- Record updated
- 4 March 2025
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Subjects with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder; Subject has an infection at implant site; Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease; Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement; Subject is unable or does not have the necessary assistance to properly operate the device system; Pregnancy.