OASIS: RetrOspective Analysis on EEGs for Identifying Seizure Susceptibility in paediatrIcs Using biomarkerS

NCT ID: NCT06546410

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-01-01

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

Conditions

Epilepsy; Epilepsy in Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Epilepsy

BioEP

Intervention Type: DEVICE

All patient's EEG will have the BioEP score conducted on it

Non-epilepsy

BioEP

Intervention Type: DEVICE

All patient's EEG will have the BioEP score conducted on it

Interventions

BioEP

All patient's EEG will have the BioEP score conducted on it

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuronostics Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Milaana Mainstone

Role: STUDY_DIRECTOR

Neuronostics Ltd

Central Contacts

Milaana Mainstone

Role: CONTACT

m.mainstone@neuronostics.com

+4401174572292

Other Identifiers

NNBioEP005

Identifier Type: -

Identifier Source: org_study_id