Epilepsy, Epilepsy in Children
Conditions
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
Interventions
DEVICEBioEP
All patient's EEG will have the BioEP score conducted on it
Sponsors
Neuronostics Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy. | 1 year | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year | Reduction in time and cost to patients with the use of BioEP |
Countries
United Kingdom
Contacts
STUDY_DIRECTORWessel Woldman
Neuronostics Ltd
Outcome results
None listed