NCT06855901Recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Feb 2025
- Start date
- 17 Jan 2024
- Primary completion date
- 31 May 2026
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Diseases
- Epilepsy
- NCT number
- NCT06855901
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 17 Jan 2024 to the primary completion date, 31 May 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Subjects with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder;
- Subject has an infection at implant site;
- Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease;
Other
- Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement;
- Subject is unable or does not have the necessary assistance to properly operate the device system.
- Pregnancy
Who the study is looking for
- 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);
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| S.S.D. Neurofisiologia Clinica - AOU di Modena Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Federico II - Napoli Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Roma | Italy | Not yet recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina Coordinator of this site? Confirm its status | Trieste | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.