High similarity between EEG from subcutaneous and proximate scalp electrodes in patients with temporal lobe epilepsy.
Sigge Weisdorf, Sirin W Gangstad, Jonas Duun-Henriksen...
https://pubmed.ncbi.nlm.nih.gov/29995605Actively Recruiting
Phase Not Applicable
Age: 12Years +
All Genders
ID06855901
Home Ultra-longterm EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies Using a Minimally Invasive Wearable Device
Led by Azienda Ospedaliero-Universitaria di Modena · Updated on 2025-03-04
30
Participants Needed
4
Research Sites
30 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliero-Universitaria di Modena
Lead Sponsor
A
Azienda Ospedaliera Universitaria Federico II (AOU Federico II)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with drug-resistant epilepsies, developmental and epileptic encephalopathies (DEE), or rare epilepsies to develop a personalized care model using a minimally invasive, wearable, subcutaneous EEG device (sqEEG) for ultra-long-term monitoring at home. The study aims to assess the device's ability to reliably detect seizures over extended periods, verify automated seizure detection algorithms, and evaluate how the collected data may improve clinical management and treatment outcomes. This approach hopes to reduce hospitalization side effects and provide accurate seizure quantification in real-life settings to enhance quality of life. The study involves two parts: an initial short-term inpatient phase where subcutaneous EEG electrodes are implanted by a neurosurgeon and tested alongside standard video-EEG monitoring in an Epilepsy Monitoring Unit. This phase evaluates the device's safety, sensitivity, tolerability, and algorithm accuracy. The second, core part consists of home-based monitoring using the wearable device for at least 12 weeks, with an optional extension up to 24 weeks if deemed beneficial. Participants continue their usual anti-seizure medication adjustments during this time, while device usage and adverse effects are closely tracked. Participants will document seizure events in diaries, supported by caregivers if needed, while weekly reviews of EEG data and safety assessments occur. The study team will compare seizure reports from the device, diaries, and clinical evaluations to determine accuracy and potential impact on patient care. After the home monitoring period, the implanted electrode is removed, and a follow-up visit is planned. Data collected will assess device safety, seizure detection accuracy, and the clinical usefulness of long-term EEG monitoring in managing epilepsy.
CONDITIONS
Brief Title
Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies
Who Can Participate
Age: 12Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age over 12 years, with or without intellectual disabilities
- Diagnosis of drug-resistant seizures, developmental epileptic encephalopathies, or rare epilepsies
- Presence of one or more seizure types defined by previous epilepsy history
- Availability to participate for the study duration of at least 3 months
You will not qualify if you...
- Presence of psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, or schizoaffective disorder
- Skeletal deformities or damage at the proposed implantation site preventing electrode placement
- Infection at the implant site
- High risk of surgical complications such as active systemic infection or hemorrhagic disease
- Use of medical devices delivering electrical energy near implant (e.g. cochlear implants)
- Profession or hobby with high risk of trauma to device or implant site (e.g. martial arts, boxing)
- Contraindication to local anesthetic drugs used during implantation and removal
- Inability or lack of assistance to properly operate the device system
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for recruitment and consent
Surgery
Duration - Single day procedure with recovery
Participants undergo implantation of subcutaneous EEG electrodes by a surgeon or neurosurgeon under local anesthesia to place electrode contacts over the seizure focus.
1 visit for implantation surgery
Surgery and Immediate Post-operative Care
Duration - 2 days to 2 weeks
Participants are admitted to the Epilepsy Monitoring Unit (EMU) for 2 days up to 2 weeks to record seizures using video-EEG and subcutaneous EEG (sqEEG), testing the sensitivity, safety, and tolerability of the device in a clinical setting.
Continuous monitoring during EMU admission
Implementation
Duration - At least 12 weeks, up to 24 weeks
Participants are discharged home with the implanted device for ultra-longterm EEG monitoring to assess seizure detection sensitivity, device tolerability, and safety in their daily environment.
Weekly visits for device assessment and data collection
Follow-up
Duration - Post-monitoring period following device removal
After home monitoring, participants have the subscalp electrode removed and a follow-up visit is planned according to clinical practice.
1 visit for device removal and follow-up
Trial Site Locations
Total: 4 locations
1
Ospedale pediatrico Bambino Gesù
Roma, Italy, Italy, 00165
Not Yet Recruiting
2
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy, Italy, 34128
Not Yet Recruiting
3
S.S.D. Neurofisiologia Clinica - AOU di Modena
Modena, Taly, Italy, 41126
Actively Recruiting
4
Azienda Ospedaliero Universitaria Federico II - Napoli
Naples, Taly, Italy, 80131
Not Yet Recruiting
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Research Team
S
Stefania Maffei, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Published Research Related To This Trial
Signal quality and power spectrum analysis of remote ultra long-term subcutaneous EEG.
Pedro F Viana, Line S Remvig, Jonas Duun-Henriksen...
https://pubmed.ncbi.nlm.nih.gov/34250608230 days of ultra long-term subcutaneous EEG: seizure cycle analysis and comparison to patient diary.
Pedro F Viana, Jonas Duun-Henriksen, Martin Glasstëter...
https://pubmed.ncbi.nlm.nih.gov/33275838What are the epileptic encephalopathies?
Marina Trivisano, Nicola Specchio
https://pubmed.ncbi.nlm.nih.gov/32049741International League Against Epilepsy classification and definition of epilepsy syndromes with onset in childhood: Position paper by the ILAE Task Force on Nosology and Definitions.
Nicola Specchio, Elaine C Wirrell, Ingrid E Scheffer...
https://pubmed.ncbi.nlm.nih.gov/35503717Detecting temporal lobe seizures in ultra long-term subcutaneous EEG using algorithm-based data reduction.
Line S Remvig, Jonas Duun-Henriksen, Franz Fürbass...
https://pubmed.ncbi.nlm.nih.gov/35987094Expert Perspective: Who May Benefit Most From the New Ultra Long-Term Subcutaneous EEG Monitoring?
Jay Pathmanathan, Troels W Kjaer, Andrew J Cole...
https://pubmed.ncbi.nlm.nih.gov/35126304The Individual Ictal Fingerprint: Combining Movement Measures With Ultra Long-Term Subcutaneous EEG in People With Epilepsy.
Troels W Kjaer, Line S Remvig, Asbjoern W Helge...
https://pubmed.ncbi.nlm.nih.gov/35002910Systematic Review of N-of-1 Studies in Rare Genetic Neurodevelopmental Disorders: The Power of 1.
Annelieke R Müller, Marion M M G Brands, Peter M van de Ven...
https://pubmed.ncbi.nlm.nih.gov/33504638Diagnostic challenges in epilepsy: seizure under-reporting and seizure detection.
Christian E Elger, Christian Hoppe
https://pubmed.ncbi.nlm.nih.gov/29452687