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NCT Number: NCT06669364

A Retrospective Study to Validate 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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months

    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.

Secondary outcomes

  1. To examine whether the use of BioEP could support a more efficient patient pathway to diagnosis

    Time frame: 6 months

    To assess if BioEP can positively influence the patient pathway by reducing number of clinical appointments to diagnosis

Study contacts

Contact information is provided by the study sponsor or research team.

Milaana Mainstone

CONTACT

[email protected]

+44 (0)117 457 2292

Sponsors and collaborators

Lead sponsor

Neuronostics Ltd

Industry

Registry information

Official study title

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

Acronym: SOLITAIRE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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