30
Participants
Start Date
January 17, 2024
Primary Completion Date
May 31, 2026
Study Completion Date
December 30, 2026
Ultra-longterm EEG monitoring at home by means of a scubscalp electrode implant.
"Subjects with uncontrolled seizures previously investigated in outpatients epilepsy clinics and for whom an admission to the Epilepsy Monitoring Unit is indicated by clinical practice, will be screened for eligibility.~Implantation of subcutaneous EEG electrodes will be done at each Research Unit by a neurosurgeon/surgeon. The implantation procedure will consist of placing subcutaneously the electrode contacts over the site of the suspected seizure focus as defined by a previous Video-EEG and neuroimaging evaluations. Surgical procedures will be performed under local anesthesia. If the device is well-tolerated, all the subjects will proceed to the extended home monitoring study, which is the core of the study protocol. The aim of the extended study is to assess sensitivity of seizure detection of sqEEG in comparison to subject's home diary, and the tolerability and safety of sqEEG in a period of 6 months."
NOT_YET_RECRUITING
Azienda Sanitaria Universitaria Giuliano Isontina, Trieste
RECRUITING
S.S.D. Neurofisiologia Clinica - AOU di Modena, Modena
NOT_YET_RECRUITING
Azienda Ospedaliero Universitaria Federico II - Napoli, Napoli
NOT_YET_RECRUITING
Ospedale pediatrico Bambino Gesù, Roma
Azienda Ospedaliera Universitaria Federico II (AOU Federico II)
UNKNOWN
Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy
UNKNOWN
Ospedale Pediatrico Bambino Gesù, Rome (IT)
UNKNOWN
Azienda Ospedaliero-Universitaria di Modena
OTHER