Clinical trial NCT06546410: OASIS: RetrOspective Analysis on EEGs for Identifying Seizure Susceptibility in paediatrIcs Using biomarkerS
Official title: A Retrospective Multisite Analysis of Routinely Collected Outpatient EEGs for Identifying Seizure Susceptibility in Paediatric Epilepsy Using Computational Biomarkers.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epilepsy
Epilepsy in Children
Lead sponsor: Neuronostics Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Paediatric population with a diagnosis of epilepsy.

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


Eligibility criteria: 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).

Primary outcomes:
measure: To validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy.
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Neuronostics Ltd
name: Milaana Mainstone
role: STUDY_DIRECTOR
References: