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

NCT06546410 | Not Yet Recruiting

• 1 other identifier: NNBioEP005
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Conditions

Epilepsy; Epilepsy in Children

Outcome Measures

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)

  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

  1 year

Study Arms (2)

Epilepsy

Device: BioEP

Non-epilepsy

Device: BioEP

Interventions

BioEP DEVICE

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

Epilepsy; Non-epilepsy

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Paediatric population with a diagnosis of epilepsy.

You may qualify if:

• ≥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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Neuronostics Ltd: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Milaana Mainstone

  Neuronostics Ltd

  STUDY DIRECTOR

Central Study Contacts

Milaana Mainstone

CONTACT

+4401174572292; m.mainstone@neuronostics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08