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Completed

NCT Number: NCT06546410

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

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

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alder Hey Children's NHS Foundation Trust, Liverpool, United Kingdom

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

BioEP

Device

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

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.

    Time frame: 1 year

    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)

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

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Neuronostics Ltd

Industry

Registry information

Official study title

A Retrospective Multisite Analysis of Routinely Collected Outpatient EEGs for Identifying Seizure Susceptibility in Paediatric Epilepsy Using Computational Biomarkers.

Acronym: OASIS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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