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CompletedNCT06546410OASISUpdated Jul 30, 2026

OASIS: RetrOspective Analysis on EEGs for Identifying Seizure Susceptibility in paediatrIcs Using biomarkerS

An observational study in Epilepsy and Epilepsy in Children, sponsored by Neuronostics Ltd. Completed at 7 sites in United Kingdom. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Neuronostics Ltd · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
530
Ages
2 Years to 18 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Epilepsy
  • Epilepsy in Children

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03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 530 is above the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Neuronostics Ltd is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Paediatric population with a diagnosis of epilepsy.

Inclusion criteria

  • ≥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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Patient diagnosed with possible NEAD and epilepsy (dual diagnosis).
  • 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).
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
530 participants (actual)
Patient registry
No

Groups and cohorts

  • Epilepsy

    Device: BioEP

  • Non-epilepsy

    Device: BioEP

Interventions

  • DeviceBioEP

    All patient's EEG will have the BioEP score conducted on it

06

What researchers measure

Primary outcomes

  1. To validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy.

    We shall demonstrate biomarkers from those with epilepsy are distinct from controls by measuring levels of balanced accuracy (sensitivity, specificity, positive predictive ratio, negative predictive ratio, diagnostic odds ratio, and area under operator curve characteristics curve)

    Time frame: 1 year

Secondary outcomes

  1. 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

    Reduction in time and cost to patients with the use of BioEP

    Time frame: 1 year

07

Study locations

7 sites
  • Alder Hey Children's NHS Foundation Trust
    Liverpool, United Kingdom
  • Great Ormond Street Hospital for Children
    London, United Kingdom
  • Imperial College Healthcare NHS Trust
    London, United Kingdom
  • Maidstone & Tunbridge Wells NHS Trust
    Maidstone, United Kingdom
  • Manchester University NHS Foundation Trust
    Manchester, United Kingdom
  • University Hospital Southampton NHS Foundation Trust
    Southampton, SO166YD, United Kingdom
  • Worcestershire Acute Hospital NHS Trust
    Worcester, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06546410
Lead sponsor
Neuronostics Ltd
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Jan 1, 2025
Primary completion
Jan 19, 2026
Completion
Jan 19, 2026
Last update
Jul 30, 2026

Study contacts

Wessel Woldman
study director · Neuronostics Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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