EpilepsyOASISNCT06546410
OASIS: RetrOspective Analysis on EEGs for Identifying Seizure Susceptibility in paediatrIcs Using biomarkerS
An observational study of Epilepsy and Epilepsy in Children, run by Neuronostics Ltd at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Epilepsy, Epilepsy in Children
- What is being tested?
- BioEP
- Type of treatment
- Medical device
- How many people
- 530 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 1 Jan 2025to 19 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Child, Adult
Study population: Paediatric population with a diagnosis of epilepsy.
Who may be able to join
- ≥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.
Who cannot join
- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Alder Hey Children's NHS Foundation Trust
Liverpool
Great Ormond Street Hospital for Children
London
Imperial College Healthcare NHS Trust
London
Maidstone & Tunbridge Wells NHS Trust
Maidstone
Manchester University NHS Foundation Trust
Manchester
University Hospital Southampton NHS Foundation Trust
Southampton, SO166YD
Worcestershire Acute Hospital NHS Trust
Worcester
About this study
Official title: A Retrospective Multisite Analysis of Routinely Collected Outpatient EEGs for Identifying Seizure Susceptibility in Paediatric Epilepsy Using Computational Biomarkers.
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
- Being tested
- BioEP
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioEPDevice
All patient's EEG will have the BioEP score conducted on it
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy | Not described Receives: Device: BioEP | |
| Non-epilepsy | Not described Receives: Device: BioEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2025
- Primary completion19 Jan 2026
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronostics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wessel Woldman, Study director, Neuronostics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546410
- Sponsor's protocol ID
- NNBioEP005
- Acronym
- OASIS
- Status last verified
- Jul 2026
- First submitted
- 6 Aug 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multisite Analysis of Routinely Collected Outpatient EEGs for Identifying Seizure Susceptibility in Paediatric Epilepsy Using Computational Biomarkers.
- ClinicalTrials.gov ID
- NCT06546410
- Acronym / sponsor ID
- OASIS / NNBioEP005
- Conditions
- Epilepsy, Epilepsy in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Neuronostics LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epilepsy | – | Device: BioEP |
| Non-epilepsy | – | Device: BioEP |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Paediatric population with a diagnosis of epilepsy.
Key inclusion criteria (8 listed)
- ≥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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioEPAll patient's EEG will have the BioEP score conducted on it | Device | Epilepsy, Non-epilepsy |
Primary outcome
To validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy.
Time frame: 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)
1 secondary outcome
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
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wessel Woldman study director
Neuronostics Ltd
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Epilepsy in Children, run by Neuronostics Ltd at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.