S100B in the Care of Non-traumatic Headaches in the Emergency Department (S100B-Céph)

S100B Protein Measures 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.

Study Overview

• Status: Completed
• Conditions: Headache
• Intervention / Treatment: Biological: Plasma S100B levels at inclusion; Device: Magnetic resonance imaging

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The study population; The study population consists of consecutive headache patients (visual analogue scale > 3) presenting at the emergency department of the Nîmes University Hospital	Biological: Plasma S100B levels at inclusion; Patients will have blood drawn to measure plasma S100B levels at inclusion.; Device: Magnetic resonance imaging; If not performed under emergency conditions, patients will have an MRI on days 2-4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S100B protein level (ng/ml)		Day 0
The presence/absence of a clinically significant anomaly on the MRI scan		Days 2-4
Final diagnostic as established by an expert committee	The diagnostic posed is either "primary headache" or "secondary headache"	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality (yes/no)	"Mortality" refers to whether or not the subject is still alive.	Month 1
Length of stay in the emergency department (days)		Month 1
Length of stay in the hospital (days)		Month 1
White blood cell count in cerebral spinal fluid		Month 1
Red blood cell count in cerebral spinal fluid		Month 1
Cerebral spinal fluid glucose level		Month 1
Cerebral spinal fluid protein level		Month 1
Cerebral spinal fluid chloride level		Month 1
Presence/absence of enterovirus in cerebral spinal fluid	Based on qualitative result from ELISA laboratory exam.	Month 1
Presence/absence of herpes virus in cerebral spinal fluid	Based on qualitative result from ELISA laboratory exam.	Month 1
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.		Month 1
Secondary headache onset: yes/no	Was there secondary headache onset by month 1?	Month 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Romain Genre Grandpierre, MD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• Grau-Mercier L, Grandpierre RG, Alonso S, Savey A, Le Floch A, de Oliveira F, Masia T, Jory N, Coisy F, Claret PG. S100B serum level: A relevant biomarker for the management of non-traumatic headaches in emergency care? Am J Emerg Med. 2023 Jun;68:132-137. doi: 10.1016/j.ajem.2023.03.036. Epub 2023 Mar 25.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimated): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging
• Other Study ID Numbers: LOCAL/2015/RGG-01; 2016-A00013-48 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No