Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-72
SponsorPoitiers University Hospital

About this trial

We aimed to conduct a prospective longitudinal interventionnal monocentric study to assess the ability of seven tesla MRI to detect diffuses axonal lesions in patients presenting a post concussional syndrom (PCS) at seven days about a mild traumatic brain injury (MTBI). Our first objective was to evaluate the diagnostic performance of seven tesla MRI runned at seven days after MTBI among patients presenting a PCS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Mild traumatic brain injury with glascow included between 13 and 15, with indication of scan

possibilty of performing an MRI at 7 days

Patient able to get to MRI at Day 7

Free consentement to the study

Disqualifiers

Patient does not hospitalized about head trauma

Inhability to move out for run the seven day MRI

Contraindication for MRI

Patient having already consulted the emergency for head trauma requiring imaging

Trial design

Design model

Single group

Treatments tested in this trial

  • 7T MRI

    Other intervention

    Seven tesla brain MRI (7T MRI) at day 7 in patients suffering from post concussionnal symptoms after mild traumatic brain injury admitted to emergency departement of Poitiers CHU (University Hospital

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: 7T MRIOther 1 intervention

Trial outcomes

Primary outcomes

1

Determine the diagnostic performance of 7 Tesla MRI performed of mild head trauma for the occurrence of post-concussion syndrome (PCS)

appearance of diffuse axonal lesions

Time frame
Day 7

Secondary outcomes

1

Evaluate the S100b dosed at admission is correlated with the occurrence of post concussion syndrome after a mild head injury.

Value of S100b dosed at admission

Time frame
Day 0
2

Evaluate the S100b dosed at admission is correlated with diffuse axonal lesion

appearance of diffuse axonal lesion and S100b dosed at admission

Time frame
Day 7, Month 6, Month 12
3

Assess the quality of life of patients suffering for post-cocussion syndrome

quality of life EQ-5D-5L questionary (score ranging from levels 1, 2, 3 (without problems) and levels 4,5 (with problems) and GOS-E scales (score ranging from 1.1 (good recovery) to 5 (death).

Time frame
Day 7, Month[6;12]
4

Correlation the association between the alteration of the anisotropy fraction (AF) and post-concussion syndrome on the MRI diffusion tensor (DTI) sequence

Focal alteration of AF data on a DTI sequence.

Time frame
Day 7

Other outcomes

Sponsors and contacts

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