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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT07527754
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 14, 2026
Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: S100B Evaluation Cohort for Transient Loss of Consciousness

Primary Outcome Measure

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 ]

Central Contacts

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