Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Determine the diagnostic performance of 7 Tesla MRI performed of mild head trauma for the occurrence of post-concussion syndrome (PCS)
研究概览
简要总结
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.
详细描述
Among patients admitted in emergency care units in France for mild traumatic brain injury, 10 % will develop post concussionnal symptoms. The variability of the clinical presentation lead to a syndrome at the border of neurology, psychiatry and neuro-traumatology. Ninety per cent of these patients will have a favorable evolution in three to six months while ten per cent will have persistant symptoms : dizziness, headache, nausea, drowsiness, anxio-depressive symptoms, irritability, memory impairments, attentionnal disorders. This conduct to an additionnal medical and social cost (medical re-consultation in emergency services, pharmaceutical expenditure due to over medication, social recognition, deterioration of social and professionnal relationships …). The litterature data show the presence of diffuse axonal lesions (DAL) frequently observed in patients victims of MTBI. These lesions seemed to be correlate with the occurrence of post concussional symptoms. New brain imagery have lead to these discoveries but are not relevant in clinical routine (functionnal MRI, Diffusion Tensor Imaging, tractography). Computed Tomography is often normal and not able to detect these lesions. Standard MRI is not enough sensible for the detection of the DAL. Some autor shows alose that his sensibility decrease in time.
These observations and encouraging results lead us to initiate a prospective interventionnal, longitudinal, pilot study monocentric using seven tesla MRI to evaluate its input in the detection of diffuse axonal lesions among patients presenting post concussionnal symptoms after a mild traumatic brain injury at day seven after they are admitted to our emergency service.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Any measure of guardianship or curatorship , any link of subordination
排除标准
- •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
- •Patients with psychiatric troubles : bipolarity, panic trouble, depressive trouble, schizophrenia
- •Patient already enrolled in the study
- •History of brain, tumor or neurosurgery
- •Untreated or poorly treated chronic vertigo
- •Untreated or poorly treated chronic migraines
- •Claustrophobia
- •BMI > 40
- •Refusal of consent to take part of the study
- •No social welfare or inhability to benefit of it by a third party
- •Patients with enhanced protection : minor aged under 18 ; person with freedom restriction by justice decision or administrative ; homeliving in health or social establishment ; adult in legal protection
- •Pregnant and nursing women
研究组 & 干预措施
7T MRI
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
干预措施: 7T MRI (Other)
结局指标
主要结局
Determine the diagnostic performance of 7 Tesla MRI performed of mild head trauma for the occurrence of post-concussion syndrome (PCS)
时间窗: Day 7
appearance of diffuse axonal lesions
次要结局
- Assess the quality of life of patients suffering for post-cocussion syndrome(Day 7, Month[6;12])
- Correlation the association between the alteration of the anisotropy fraction (AF) and post-concussion syndrome on the MRI diffusion tensor (DTI) sequence(Day 7)
- Evaluate the S100b dosed at admission is correlated with the occurrence of post concussion syndrome after a mild head injury.(Day 0)
- Evaluate the S100b dosed at admission is correlated with diffuse axonal lesion(Day 7, Month 6, Month 12)
- Compare the performance obtained on cognitive functioning as a function of cognitive reserve(Month 3)
- Describe the diagnostic performance of the 7 T MRI and quality of life on the occurrence of a post-concussion syndrome(Month [3;6;12])
- Compare in patients the presence of anxio-depressive syndrome(Month 3)
- Correlation the association between the presence of a lesion on 7T MRI and the results of various neuropsychological tests.(Month 12)