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

RecruitingNAAges 12 Years - anyAllAzienda Ospedaliero-Universitaria di Modena
NCT06855901 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
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
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What it tests

  • Ultra-longterm EEG monitoring at home by means of a scubscalp electrode implant.
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Where

4 sites
Ospedale pediatrico Bambino Gesù
Roma, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy
S.S.D. Neurofisiologia Clinica - AOU di Modena
Modena, Italy
Azienda Ospedaliero Universitaria Federico II - Napoli
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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