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

Neuronostics

Status

Not yet enrolling

Conditions

Epilepsy

Epilepsy in Children

Treatments

Device: BioEP

Study type

Observational

Funder types

Industry

Identifiers

NCT06546410

NNBioEP005

Details and patient eligibility

About

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

Enrollment

500 estimated patients

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

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).