Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies
Recruiting · NCT06855901 · Interventional (participants receive a specific treatment) · Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
4 locations listed.
- Ospedale pediatrico Bambino Gesù - Roma, Italy, Italy
- Azienda Sanitaria Universitaria Giuliano Isontina - Trieste, Italy, Italy
- S.S.D. Neurofisiologia Clinica - AOU di Modena - Modena, Taly, Italy
- Azienda Ospedaliero Universitaria Federico II - Napoli - Naples, Taly, Italy