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

Not yet recruiting

• Conditions: Epilepsy; Epilepsy in Children
• Interventions: Device: BioEP

• Registration Number: NCT06546410
• Lead Sponsor: Neuronostics Ltd

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Start: 2025-01-01
• Primary Completion: 2025-07-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Epilepsy	BioEP	-
Non-epilepsy	BioEP	-

Primary Outcome Measures

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

Name	Time	Method
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	1 year	Reduction in time and cost to patients with the use of BioEP