A Retrospective Study to Validate BioEP as an Assessment Aid for Seizure Susceptibility (SOLITAIRE)

Retrospective Analysis of Routine EEG to Validate a Computational Biomarker (BioEP) as an Assessment Aid for Seizure Susceptibility.

The goal of this retrospective study is to validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known epilepsy diagnosis. The main objectives of the study are:

• To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis
• 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 Overview

• Status: Not yet recruiting
• Conditions: Epilepsy

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Milaana Mainstone; Phone Number: +44 (0)117 457 2292; Email: m.mainstone@neuronostics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult population with a diagnosis of epilepsy

Description

Inclusion Criteria:

• Adults (age 22 and above) who had a routine EEG in an outpatient setting, following a suspected seizure.
• A diagnosis of epilepsy or alternate condition has been reached. A period of at least 3 years has passed since ultimate diagnosis, which itself has remained stable.
• EEGs performed to ABRET & IFCN standards using a minimum of 19 electrodes and additional technical requirements.

Exclusion Criteria:

• Subject was not suspected of having had a seizure or epilepsy.
• Subject has a dual diagnosis of epilepsy AND non-epileptic seizures.
• Subject's final diagnosis unknown, unstable, or less than three years passed since an unchanged diagnosis was made.
• Incomplete or unreliable metadata, such as the age, sex, and treatment status at the time of the EEG recording.
• Sleep deprived EEG recordings in the outpatient setting.
• Encephalopathic subjects.
• Poor quality EEGs (multiple artefacts) that do not fulfil technical criteria for analysis.
• Known structural abnormalities or skull breaches, including historical cases, or with people with metal or plastic implants in their brain or skull.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Epilepsy; Device: BioEP All patient's EEG will have the BioEP score conducted on it
Non-epilepsy; Device: BioEP All patient's EEG will have the BioEP score conducted on it

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To validate BioEP during routine adult EEG recording in an outpatient setting, using patients with a known diagnosis	Diagnostic accuracy, defined by a primary endpoint family1 of two ranked endpoints. Specifically, we are testing whether BioEP has superior sensitivity to initial EEG alone and is no worse than EEG alone for specificity (non-inferiority). These are ranked hypotheses with sensitivity taking precedence (fixed sequence method) . That is, we shall only proceed to comparing specificity if sensitivity is superior.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis	To assess if BioEP can positively influence the patient pathway by reducing number of clinical appointments to diagnosis	6 months

Collaborators and Investigators

• Sponsor: Neuronostics Ltd
• Investigators: Study Director: Milaana Mainstone, Neuronostics Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Seizures
• Other Study ID Numbers: NNBioEP003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No