EpilepsyEPILEPSYNCT07527754
S100B Protein: a Diagnostic Aid in Episodes of Transient Loss of Consciousness?
An observational study of Epilepsy and Cryptogenic Epilepsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Cryptogenic Epilepsy
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2026to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients presenting to the Emergency Department of Henri Mondor University Hospital during the inclusion period for an episode of transient loss of consciousness. Eligible patients will be screened consecutively and included if they meet all predefined inclusion criteria and none of the exclusion criteria.
Who may be able to join
- • 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
Who cannot join
- 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
Show all 9Show fewer
- Individuals under legal protection:
- Placed under guardianship
- Deprived of liberty (incarcerated or hospitalized without consent)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Henri Mondor
Créteil, Île-de-France Region, 94000
Christian KASSASSEYA, Dr, 01.49.81.21.11, christian.kassasseya@aphp.fr
About this study
Official title: Diagnostic Performance of S100B Protein Measurement in Episodes of Transient Loss of Consciousness: a Prospective Cohort Study
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.
- Conditions
- Epilepsy, Cryptogenic Epilepsy
- Keywords
- Biomarker-guided diagnosis, Diagnostic differentiation between epilepsy and other causes of transient loss of consciousness, Early diagnostic orientation in the Emergency Department, Diagnostic performance of S100B measurement in transient loss of consciousness
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| S100B Evaluation Cohort for Transient Loss of Consciousness | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the ROC curve (AUROC) of S100B measurement, assessing its ability to discriminate epilepsy from other causes of transient loss of consciousness
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.
Measured: 15 Months
Secondary outcomes (7)
Determination of the optimal S100B threshold for the diagnosis of epilepsy using Youden's index
Measured: 15 months
Assessment of the diagnostic performance associated with the optimal S100B threshold for epilepsy diagnosis (sensitivity, specificity, positive predictive value, and negative predictive value).
Measured: 15 months
Subgroup analyses based on adjudicated etiological diagnoses
Diagnostic performance of S100B will be evaluated separately within each etiological subgroup defined by the adjudication committee (epilepsy, cardiac syncope, hypoglycemia, vasovagal syncope)
Measured: 15 Months
Analysis of S100B levels according to patient comorbidities
Plasma S100B concentrations will be measured using standard immunoassay techniques.
Measured: 15 months
Analysis of results based on the time between symptom onset and sample collection (in hours).
Measured: 15 months
Analysis of results according to patient age (<65 years, 65-79 years, and ≥80 years).
Measured: 15 months
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).
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527754
- Sponsor's protocol ID
- APHP251504
- Acronym
- EPILEPSY
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of S100B Protein Measurement in Episodes of Transient Loss of Consciousness: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07527754
- Acronym / sponsor ID
- EPILEPSY / APHP251504
- Conditions
- Epilepsy, Cryptogenic Epilepsy
- Keywords
- Biomarker-guided diagnosis, Diagnostic differentiation between epilepsy and other causes of transient loss of consciousness, Early diagnostic orientation in the Emergency Department, Diagnostic performance of S100B measurement in transient loss of consciousness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 14 Apr 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S100B Evaluation Cohort for Transient Loss of Consciousness | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients presenting to the Emergency Department of Henri Mondor University Hospital during the inclusion period for an episode of transient loss of consciousness. Eligible patients will be screened consecutively and included if they meet all predefined inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (6 listed)
- • Adult ≥ 18 years old
Key exclusion criteria (9 listed)
- Symptoms occurring more than 12 hours ago
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Determination of the optimal S100B threshold for the diagnosis of epilepsy using Youden's index
Time frame: 15 months
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
Subgroup analyses based on adjudicated etiological diagnoses
Time frame: 15 Months
Analysis of S100B levels according to patient comorbidities
Time frame: 15 months
Analysis of results based on the time between symptom onset and sample collection (in hours).
Time frame: 15 months
Analysis of results according to patient age (<65 years, 65-79 years, and ≥80 years).
Time frame: 15 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
1 site 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 Cryptogenic Epilepsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian KASSASSEYA, Dr (01.49.81.21.11, christian.kassasseya@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). 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 14 Apr 2026.