Traumatic Brain Injury
Conditions
Brief summary
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.
Interventions
RADIATIONMagnetic Resonance Imaging
IRM Sequences T1, T2, FLAIR, T2\*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)
Sponsors
Regional Council of Auvergne-Rhône-Alpes
University Hospital, Grenoble
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Intervention model description
prospective, monocentric, etiological cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 months | 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. |
| Graph metrics in resting-state functional magnetic resonance imaging in both groups | 3 months | Describe the graph metrics in resting-state functional MRI in both groups |
| Clinical correlation of magnetic resonance imaging with symptoms. | 3 months | Look for a clinical correlation between psychological evaluation tests and magnetic resonance imaging observations such as damages zones. |
| Describe in both groups, the evolution of symptomatology at one year | 12 months | 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. |
| Describe correlation between anamnestic risk factors, demographic data and post-concussion syndrome occurence | 3 months | 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. |
| Evaluate the impact of social characteristics at stake and the resources mobilized | 6 months | 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 |
| Evaluate the impact of social characteristics and the resources mobilized | 12 months | 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 |
| 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. | 6 months | 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. |
| Evaluate the impact of mTBI on patients' lifestyles | 6 months | Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion. |
Countries
France
Outcome results
None listed