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

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 17, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

December 30, 2026

Conditions
EpilepsiesEpilepsies, FocalEpileptic Encephalopathy
Interventions
DEVICE

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."

Trial Locations (4)

34128

NOT_YET_RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina, Trieste

41126

RECRUITING

S.S.D. Neurofisiologia Clinica - AOU di Modena, Modena

80131

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Federico II - Napoli, Napoli

00165

NOT_YET_RECRUITING

Ospedale pediatrico Bambino Gesù, Roma

All Listed Sponsors
collaborator

Azienda Ospedaliera Universitaria Federico II (AOU Federico II)

UNKNOWN

collaborator

Azienda Sanitaria Universitaria Giuliano Isontina [ASUGI], Università di Trieste, Italy

UNKNOWN

collaborator

Ospedale Pediatrico Bambino Gesù, Rome (IT)

UNKNOWN

lead

Azienda Ospedaliero-Universitaria di Modena

OTHER