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Completed

NCT Number: NCT02683304

S100B in the Care of Non-traumatic Headaches in the Emergency Department

The main objective of this pilot study is to make a first assessment of the discriminating ability of a dosage of S100B protein for differential diagnosis between primary headaches and secondary headaches.

For this, the investigators will compare serum S100B protein between two groups of headache patients presenting at the emergency department: 1 group of primary headache patients and 1 group of secondary headache patients.

If the difference between the two groups proves potentially discriminating, the investigators will seek to determine the discriminating ability of the S100B protein by calculating the area under the ROC curve.

The reference diagnostic will be set at one month across the entire clinical picture and imaging by an expert committee composed of a neurologist, a radiologist and an emergency physician.

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Key information

Conditions

Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

The secondary objectives of this study are:

A. To seek an association between S100B protein levels and the onset of pain depending on whether it is more or less than 3 hours.

B. To assess the association between S100B protein levels and mortality at day 28.

C. To evaluate the association between S100B protein levels and hospital care: average length of stay in the emergency department, lumbar puncture, brain imaging, average length of hospital stay.

D. To evaluate the prognostic value of determination of S100B protein on the occurrence of a secondary headache at 1 month.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient has nontraumatic headache pain with a visual analog scale > 3

Exclusion criteria

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • The patient has a contraindication for magnetic resonance imaging
  • Patients suffering from the following diseases: Alzheimer's disease, multiple sclerosis, Creutzfeldt-Jakob disease, melanoma, trisomy 21.

Treatment and study plan

Plasma S100B levels at inclusion

Biological

Patients will have blood drawn to measure plasma S100B levels at inclusion.

Magnetic Resonance Imaging

Device

If not performed under emergency conditions, patients will have an MRI on days 2-4.

Primary outcomes

  1. S100B protein level (ng/ml)

    Time frame: Day 0

  2. The presence/absence of a clinically significant anomaly on the MRI scan

    Time frame: Days 2-4

  3. Final diagnostic as established by an expert committee

    Time frame: Month 1

    The diagnostic posed is either "primary headache" or "secondary headache"

Secondary outcomes

  1. Mortality (yes/no)

    Time frame: Month 1

    "Mortality" refers to whether or not the subject is still alive.

  2. Length of stay in the emergency department (days)

    Time frame: Month 1

  3. Length of stay in the hospital (days)

    Time frame: Month 1

  4. White blood cell count in cerebral spinal fluid

    Time frame: Month 1

  5. Red blood cell count in cerebral spinal fluid

    Time frame: Month 1

  6. Cerebral spinal fluid glucose level

    Time frame: Month 1

  7. Cerebral spinal fluid protein level

    Time frame: Month 1

  8. Cerebral spinal fluid chloride level

    Time frame: Month 1

  9. Presence/absence of enterovirus in cerebral spinal fluid

    Time frame: Month 1

    Based on qualitative result from ELISA laboratory exam.

  10. Presence/absence of herpes virus in cerebral spinal fluid

    Time frame: Month 1

    Based on qualitative result from ELISA laboratory exam.

  11. Presence/absence of cerebral imaging indicating an ischemic or hemorrhagic stroke, subarachnoid hemorrhage, an expansive process, cerebral trombophlebitis cerebral or other abnormalities suggestive of a secondary cause of headache.

    Time frame: Month 1

  12. Secondary headache onset: yes/no

    Time frame: Month 1

    Was there secondary headache onset by month 1?

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department

Acronym: S100B-Céph

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2016
Registry last updated
Dec 1, 2025

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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