Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07527754

S100B Protein: a Diagnostic Aid in Episodes of Transient Loss of Consciousness?

S100B protein is a biomarker produced mainly by astrocytes and released into the bloodstream in the event of brain injury, with levels rising rapidly and markedly in acute conditions such as traumatic brain injury, stroke, or epileptic seizures, before declining quickly. Increased S100B levels following a convulsive seizure have been reported, suggesting potential value in distinguishing epilepsy from other causes; however, its use in the etiological assessment of transient loss of consciousness has not yet been studied. Loss of consciousness represents a common reason for Emergency Department visits and involves a wide range of causes, making diagnosis challenging due to often limited clinical history and resulting in numerous investigations. A biomarker such as S100B could help guide diagnosis more rapidly, particularly in distinguishing epilepsy from other causes, thereby reducing the need for additional tests and shortening hospital stay. To date, no study has evaluated the performance of S100B measurement in the etiological workup of transient loss of consciousness. The hypothesis underlying this study is that measurement of S100B levels in the Emergency Department could help differentiate epileptic seizures from other etiologies, particularly cardiac causes, and thus reduce additional investigations and hospital stay. This prospective observational study primarily aims to assess the diagnostic performance of S100B measurement for identifying epilepsy compared with other causes of transient loss of consciousness in adult patients presenting to the Emergency Department for this reason. The study will begin on April 30 and will last 15 months. In practice, eligible patients who do not oppose participation will undergo an additional blood sample at the time of initial sampling required for clinical management, with this sample used to measure plasma S100B levels; patient management will otherwise remain identical to standard care. Three months after the Emergency Department visit, an adjudication committee composed of a neurologist, a cardiologist, and an emergency physician will determine the final diagnosis based on all available data, including any additional investigations performed after the initial visit. The primary endpoint is the area under the ROC curve (AUROC) of S100B measurement, evaluating its ability to discriminate epilepsy from other causes of transient loss of consciousness.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Adult ≥ 18 years old
  • Presentation to the Emergency Department of Henri Mondor University Hospital
  • History of loss of consciousness
  • Undergoing a blood test as part of Emergency Department care
  • Covered by social security
  • Has agreed to participate in the study

Exclusion criteria

  • Symptoms occurring more than 12 hours ago
  • History of head trauma without brain imaging performed
  • History of head trauma with intracranial bleeding confirmed on brain imaging
  • Refusal to participate in the study
  • Pregnant and/or breastfeeding women
  • Individuals unable to provide consent, particularly due to cognitive impairment
  • Individuals under legal protection:
  • Placed under guardianship
  • Deprived of liberty (incarcerated or hospitalized without consent)

Treatment and study plan

Primary outcomes

  1. Area under the ROC curve (AUROC) of S100B measurement, assessing its ability to discriminate epilepsy from other causes of transient loss of consciousness

    Time frame: 15 Months

    The primary outcome measure is the area under the ROC curve (AUROC) of S100B measurement, assessing its ability to discriminate epilepsy from other causes of transient loss of consciousness. The reference standard is the final diagnosis established by an adjudication committee at 3 months, blinded to the S100B result. The AUROC will be estimated with its 95% confidence interval (95% CI). Statistical significance will be assessed using a test comparing the AUROC to 0.5. The test will be considered of diagnostic interest if the AUROC is ≥ 0.75 and/or if the lower bound of the 95% CI is > 0.65, and if the p-value of the test versus 0.50 is < 0.05.

Secondary outcomes

  1. Determination of the optimal S100B threshold for the diagnosis of epilepsy using Youden's index

    Time frame: 15 months

  2. Assessment of the diagnostic performance associated with the optimal S100B threshold for epilepsy diagnosis (sensitivity, specificity, positive predictive value, and negative predictive value).

    Time frame: 15 months

  3. Subgroup analyses based on adjudicated etiological diagnoses

    Time frame: 15 Months

    Diagnostic performance of S100B will be evaluated separately within each etiological subgroup defined by the adjudication committee (epilepsy, cardiac syncope, hypoglycemia, vasovagal syncope)

  4. Analysis of S100B levels according to patient comorbidities

    Time frame: 15 months

    Plasma S100B concentrations will be measured using standard immunoassay techniques.

  5. Analysis of results based on the time between symptom onset and sample collection (in hours).

    Time frame: 15 months

  6. Analysis of results according to patient age (<65 years, 65-79 years, and ≥80 years).

    Time frame: 15 months

  7. Analysis of results based on the occurrence of head trauma during the episode and, if applicable, the time between the trauma and the measurement of S100B (in hours).

    Time frame: 15 months

Study contacts

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

Christian KASSASSEYA, Dr

CONTACT

[email protected]

01.49.81.21.11

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Diagnostic Performance of S100B Protein Measurement in Episodes of Transient Loss of Consciousness: a Prospective Cohort Study

Acronym: EPILEPSY

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

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.

Published trials that share one or more normalized conditions with this study.