OASIS: RetrOspective Analysis on EEGs for Identifying Seizure Susceptibility in paediatrIcs Using biomarkerS
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-16
SponsorNeuronostics Ltd
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥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.
Disqualifiers
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.
Trial population
Paediatric population with a diagnosis of epilepsy.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
BioEP
DeviceAll patient's EEG will have the BioEP score conducted on it
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Epilepsy1 intervention
Group B: Non-epilepsy1 intervention
Trial outcomes
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)
Time frame
1 yearSecondary 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
Reduction in time and cost to patients with the use of BioEP
Time frame
1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: