NCT06855901 Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies
| NCT ID | NCT06855901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero-Universitaria di Modena |
| Condition | Epilepsies |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-01-17 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-01-17 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Stefano Meletti, MD, PhD
PRINCIPAL INVESTIGATOR
Azienda Ospedaliero Universitaria di Modena - Ospedale Civile di Baggiovara - S.S.D. Neurofisiologia
Frequently Asked Questions
Who can join the NCT06855901 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Epilepsies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06855901 currently recruiting?
Yes, NCT06855901 is actively recruiting participants. Contact the research team at maffei.stefania@aou.mo.it for enrollment information.
Where is the NCT06855901 trial being conducted?
This trial is being conducted at Roma, Italy, Trieste, Italy, Modena, Italy, Naples, Italy.
Who is sponsoring the NCT06855901 clinical trial?
NCT06855901 is sponsored by Azienda Ospedaliero-Universitaria di Modena. The principal investigator is Stefano Meletti, MD, PhD at Azienda Ospedaliero Universitaria di Modena - Ospedale Civile di Baggiovara - S.S.D. Neurofisiologia. The trial plans to enroll 30 participants.