RecruitingNot ApplicableNCT06855901

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

Home Ultra-longterm EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies. an Open Label Nonpharmacological Interventional Prospective Study by Means of Minimally Invasive Wearable EEG Device

Sponsor

Azienda Ospedaliero-Universitaria di Modena

Enrollment

30 participants

Start Date

Jan 17, 2024

Study Type

INTERVENTIONAL

Conditions

Epilepsies, Focal Epileptic Encephalopathy Epilepsies

Summary

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.

Eligibility

Min Age: 12 Years

Inclusion Criteria4

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 Criteria9

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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Interventions

DEVICEUltra-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.