Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Clinical correlation of magnetic resonance imaging with symptoms.(3 months)
- Describe in both groups, the evolution of symptomatology at one year(12 months)
- Evaluate the impact of mTBI on patients' lifestyles(12 months)
- Evaluate the impact of social characteristics and the resources mobilized(12 months)
- Describe correlation between anamnestic risk factors, demographic data and post-concussion syndrome occurence(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.(3 months)
- Graph metrics in resting-state functional magnetic resonance imaging in both groups(3 months)
- Evaluate the impact of social characteristics at stake and the resources mobilized(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.(12 months)