NCT06546410Completed
OASIS: RetrOspective Analysis on EEGs for Identifying Seizure Susceptibility in paediatrIcs Using biomarkerS
A Retrospective Multisite Analysis of Routinely Collected Outpatient EEGs for Identifying Seizure Susceptibility in Paediatric Epilepsy Using Computational Biomarkers.
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
The goal of this retrospective study is to validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy. The main objectives are: Primary: To validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy. Secondary: To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis (thus adding economic value), by reducing time to final diagnosis and/or the number of clinical appointments needed
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 530 (actual)
- First submitted
- 6 Aug 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 19 Jan 2026
- Lead sponsor
- Neuronostics Ltd
- Diseases
- Epilepsy
- NCT number
- NCT06546410
What you commit to
- Study type: Observational
- Participants enrolled: 530
- From 1 Jan 2025 to the primary completion date, 19 Jan 2026
- 7 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.
Other illness
- Patient diagnosed with possible NEAD and epilepsy (dual diagnosis).
Other
- Developmental and/or epileptic encephalopathies \[§\]
- Patients with global development delay of unknown origin.
- Patients with profound and multiple intellectual disabilities
- Participants with a known hepatic/renal encephalopathy.
- Participants taking part in another Clinical Trial of an Investigational Medicinal Product (CTIMP) (qualitative/observational studies are acceptable).
- Patients with any breaches of skull (plates, burr holes, shrapnel).
Who the study is looking for
- ≥2-\<18 years age.
- Patients who have had a confirmed epilepsy diagnosis for ≥1+ year.
- Non contributary first EEG: including routine EEG, sleep EEG (natural, melatonin induced, sleep deprived), 24-hour ambulatory EEG.
- Patients who have been diagnosed with a self-limited and or focal epilepsy \[\*\] who have had a first non-contributary (no IEDS present, negative) outpatient EEG.
- Patients who have been diagnosed with idiopathic generalised epilepsy \[†\] who have had a first non-contributary (no IEDS present, negative) routine EEG.
- Neurodiverse patients with epilepsy can be included in the study \[‡\]
- Patients with epilepsy and co-morbidities can be included in the study (anxiety, mood disorders etc)
- Controls should be EEGs taken from patients who have been referred for a paroxysmal disorder, received an EEG as part of their diagnostic work up and subsequently received an alternate diagnosis. Epilepsy should have been excluded from their differential diagnosis and the alternate diagnosis should have remained stable for ≥1+ year.
Age in the registry: 2 years to 18 years · Sex: All
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alder Hey Children's NHS Foundation Trust Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Great Ormond Street Hospital for Children Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Maidstone & Tunbridge Wells NHS Trust Coordinator of this site? Confirm its status | Maidstone | United Kingdom | Unknown status |
| Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Worcestershire Acute Hospital NHS Trust Coordinator of this site? Confirm its status | Worcester | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.