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difficulty recruiting and no sociologists
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| Name | Class |
|---|---|
| Regional Council of Auvergne-Rhône-Alpes | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic group at three month | Experimental | 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 |
|
| Asymptomatic group at three month | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Radiation | IRM Sequences T1, T2, FLAIR, T2*, Cerebral Blood Flow (CBF) et mean diffusivity (MD) |
|
| 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 |
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Grenoble Alpes | Grenoble | 38047 | France |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D007406 | Interview, Psychological |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D011580 | Psychological Techniques |
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prospective, monocentric, etiological cohort study
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|
| 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 :
| 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 :
| 12 months |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D004191 | Behavioral Disciplines and Activities |