Status:
NOT_YET_RECRUITING
OASIS: RetrOspective Analysis on EEGs for Identifying Seizure Susceptibility in paediatrIcs Using biomarkerS
Lead Sponsor:
Neuronostics Ltd
Conditions:
Epilepsy
Epilepsy in Children
Eligibility:
All Genders
2-16 years
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 partic...
Eligibility Criteria
Inclusion
- ≥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
- 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).
Key Trial Info
Start Date :
January 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06546410
Start Date
January 1 2025
End Date
January 1 2026
Last Update
August 9 2024
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