Condition: Epilepsies · Epilepsies, Focal · Epileptic Encephalopathy · Sponsor: Azienda Ospedaliero-Universitaria di Modena
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.
This description comes directly from the study's public registry record.
Stefania Maffei, PhD · +390593961157 · maffei.stefania@aou.mo.it
Always discuss trial participation with your own doctor first.
| Ospedale pediatrico Bambino Gesù | Roma, Italy, Italy | Not Yet Recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina | Trieste, Italy, Italy | Not Yet Recruiting |
| S.S.D. Neurofisiologia Clinica - AOU di Modena | Modena, Taly, Italy | Recruiting |
| Azienda Ospedaliero Universitaria Federico II - Napoli | Naples, Taly, Italy | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06855901