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
Qualifiers
≥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 design
Treatments tested in this trial
- BioEP
Treatment groups
500 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov