Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion

Study Overview
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Brief Summary
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Minor traumatic brain injury (mTBI) (Glasgow Coma Scale 13 to 15) represent 70 to 90% of traumatic brain injury. Different disorders may occur after a traumatic minor brain injury (somatic, cognitive or affective) within 2 weeks. For 10 to 20% these symptoms are persistent and are part of post-concussion syndrome. Today a small amount of tools to predict this syndrome are available. Cerebral CT scan, a routine test for mTBI, isn't relevant to predict the post concussion syndrome. In order to improve understanding of the evolution toward this complication, it seems relevant to run a multimodal study. Multiparameter MRI combined to psychological and sociological evaluations cold provide a better global perception.

Official Title
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Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Radiation: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who answered to psychological questionnaires 3 month after mTBI Patients with mTBI according to European Federation of Neurological Societies Initial CT scan indication according to 2012 French Society of Emergency Medicine and European Federation of Neurological Societies Health insurance Written consent Exclusion Criteria: Under 18 years Psychiatric or neurologic history with long term treatment Hospitalization due to extra-cranial wounds or intoxication (except alcool) MTBI due to aggression MRI contraindication Inability to understand french language Pregnant or breastfeeding women Incapacitated patients in accordance with article L 1121-5 to L1121-8 of the public health code Patients in another study's exclusion time Inability to have a follow-up Patients who can't be reached in case of emergency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, monocentric, etiological cohort study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symptomatic group at three month<br>Rivermead Post-Concussion Syndrome >= 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview 1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire | Radiation: Magnetic Resonance Imaging<br>* IRM Sequences T1, T2, FLAIR, T2*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)<br>* Other names: Psychological interview;|
| Experimental: Asymptomatic group at three month<br>Rivermead Post-Concussion Syndrome < 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview 1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire | Radiation: Magnetic Resonance Imaging<br>* IRM Sequences T1, T2, FLAIR, T2*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)<br>* Other names: Psychological interview;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the mean lesion volume fraction found in multiparametric magnetic resonance imaging between patients with and without post-concussions syndrome, three months after a mild Traumatic Brain Injury. | Mean of cerebral volume fraction corresponding to lesions areas, found in multiparametrical magnetic resonance imaging (expressed as a percentage), 3 months after mild traumatic brain injury. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe correlation between anamnestic risk factors, demographic data and post-concussion syndrome occurence | Describe correlation between risk factor and the development of post-concussion syndrome. Describe risk factors as demographic factors and medical history correlated with the development of post-concussion syndrome. The risk factors studies will be: Age (median in years) Sex Cohabitation status Education Daily consumption of alcohol Smoking Glasgow score Loss of consciousness after the trauma Associated injuries This information will be obtained using the medical record and by interviewing the patient. The presence of post-concussion syndrome will be defined using the Rivermead Post-concussion Symptoms Questionnaire. The presence of post-concussion syndrome will correspond to a score higher than 12. | 3 months | 
| Level of asymmetry of the signal between each hemisphere, for each magnetic resonance imagings equence, and with the techniques of ROI (Regions of Interests): asymmetry threshold corresponding to a lesion. | Measuring the level of asymmetry of the signal between each hemisphere, for each magnetic resonance imaging sequence, and with the techniques of ROI (Regions of Interests) ;to determine the asymmetry threshold corresponding to a lesion. | 3 months | 
| Graph metrics in resting-state functional magnetic resonance imaging in both groups | Describe the graph metrics in resting-state functional MRI in both groups | 3 months | 
| Clinical correlation of magnetic resonance imaging with symptoms. | Look for a clinical correlation between psychological evaluation tests and magnetic resonance imaging observations such as damages zones. | 3 months | 
| Describe in both groups, the evolution of symptomatology at one year | Describe in both groups, the evolution of symptomatology at one year with the Rivermead Post-Concussion Syndrome Questionnaire (RPCSQ). The Rivermead questionnaire ranges from 0 to 64. The presence of post-concussion syndrome will correspond to a score higher than 12. | 12 months | 
| Evaluate the impact of mTBI on patients' lifestyles | Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion. | 6 months | 
| Evaluate the impact of mTBI on patients' lifestyles | Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion. | 12 months | 
| Evaluate the impact of social characteristics at stake and the resources mobilized | Understand the impact of social characteristics at stake and the resources mobilized in the social life's re-establishment post TBI through a sociologic interview | 6 months | 
| Evaluate the impact of social characteristics and the resources mobilized | Understand the impact of social characteristics at stake and the resources mobilized in the social life's re-establishment post TBI through a sociologic interview | 12 months | 
| Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner. | Sociologic questionnaires to different actors of the patient recovery to understand the experience of mTBI and post-concussion syndrome : the patient's personal appreciation, the judgement of family and friends the medical follow-up of the general practitioner. | 6 months | 
| Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner. | Sociologic questionnaires to different actors of the patient recovery to understand the experience of mTBI and post-concussion syndrome : the patient's personal appreciation, the judgement of family and friends the medical follow-up of the general practitioner. | 12 months |