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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy; Epilepsy in Children
• Intervention / Treatment: Device: BioEP

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Milaana Mainstone; Phone Number: +4401174572292; Email: m.mainstone@neuronostics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Paediatric population with a diagnosis of epilepsy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epilepsy	Device: BioEP; All patient's EEG will have the BioEP score conducted on it
Non-epilepsy	Device: BioEP; All patient's EEG will have the BioEP score conducted on it

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Collaborators and Investigators

• Sponsor: Neuronostics Ltd
• Investigators: Study Director: Milaana Mainstone, Neuronostics Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: NNBioEP005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No