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临床试验/NCT01936792
NCT01936792已完成不适用

Pathology in the Brain After mTBI - A Multimodal MRI Study

University of Aarhus1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in Mean Kurtosis (MK) in mTBI subjects

研究概览

简要总结

The purpose is to use Diffusion Kurtosis Imaging (DKI), Diffusion Tensor Imaging (DTI) and resting state functional MRI to examine tissue damage in the brains of people who have had a concussion, both acute and 3 months after the accident. A secondary purpose is to examine whether the results of the scans are associated with physical, cognitive and emotional problems after concussion.

It is hypothesized that there will be a change in the diffusion signal measured with DKI in the thalamus (THA) and with DTI in the corpus callosum (CC), in the acute stage and at follow-up of the mTBI subjects compared with the healthy controls. Secondary it is expected that there will be changes in the diffusion signal measured with DKI and DTI in other WM and GM area in both the acute stage and at follow up with mTBI subjects compared with healthy controls. Also rs-fMRI markers are secondary expected to differ in the two groups. Moreover secondarily the MRI markers are tested for correlation with the severity of PCS acutely and at follow up after mTBI.

详细描述

More than 25,000 people in Denmark, are each year diagnosed with commotio cerebri as a result of head trauma (National Patient Registry, 1996), and foreign studies report that up to 5 to 15% of these have symptoms that persist beyond 3 months (5). Post commotio symptoms (PCS) are typically divided into physical, cognitive and emotional symptoms and include headache, fatigue, memory loss, stress, etc.. It is known from previous studies of traumatic brain injuries that the cost of the disabling process and the failure to intervene in the long term are very costly (11). In Denmark there are to date no systematic or consistent treatment for people with persistent symptoms 3 months after commotio cerebri, and a lack of general knowledge about the pathology and standardization with regard to diagnosis and prognosis are also missing.

Commotio cerebri, also known as mild traumatic brain injury (mTBI) is often defined as an exogenous traumatic stimulus that causes a physiological disruption of brain function (American Congress of Rehabilitation Medicine). This includes a biochemical cascade, edema, micro-haemorrhages, diffuse axonal injury (DAI) and changes in activity between internal networks in the brain (12, 13).

In severe trauma, conventional scanning methods such as Computer Tomography (CT) and Magnetic Resonance Imaging (MRI) can detect bone rupture, edema and micro-haemorrhages, but in mTBI, it is often difficult to detect edema or micro-hemorrhages, and the conventional methods is often not sensitive enough to show pathology especially beyond the acute period, although patients continue to have physical symptoms as well as cognitive and emotional problems (6, 12).

More MRI techniques, which are not routinely used in the clinic, has verified both DAI and changes in cortical network as compared to healthy controls (12). One of these is the method Diffusional tensor imaging (DTI) which can be used to detect the DAI in white matter (WM). DTI studies confirm DAI in several WM areas after mTBI (12). Other studies have shown that DAI detected by DTI in several places of WM correlates with cognitive problems after mTBI (1,2,6,13).

A more recent and less studied MRI method is Diffusional Kurtosis Imaging (DKI) which can display DAI in WM and prove to be more sensitive than the DTI for the detection of damage in gray matter (GM) (3, 4). A study in humans showed significant differences between individuals with mTBI and healthy controls, in the thalamus and several WM areas (3). This study also showed a correlation between DKI markers in the thalamus and the capsula interna with cognitive problems in multiple domains after mTBI. DKI is therefore suggested to be used in addition to DTI in relation to detect tissue damage in both WM and GM.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18-40 years
  • negative CT scan
  • A Glasgow Coma Scale (GCS) score that is higher than 13 after 30 minutes
  • one or more of the following characteristics:
  • A period of loss of consciousness for up to 30 minutes
  • A period of amnesia of events immediately before or after the accident within 24 hours before / after the episode
  • Any change in mental state at the time of the accident (eg, dazed, disoriented or confused)
  • Focal neurological deficit, which may or may not be transient

排除标准

  • Psychiatric or neurological diagnosis already
  • The use of drugs, smoking or alcohol eight hours before MRI
  • Alcohol or drug abuse
  • Former mTBI with unconsciousness within the last 2 years
  • Significant other trauma, as the primary symptom
  • MRI contraindications

结局指标

主要结局

Change in Mean Kurtosis (MK) in mTBI subjects

时间窗: from baseline within 14 days and to follow up 3 month after mTBI

MRI measurement unit

次要结局

  • Difference in MK between mTBI and control subjects(within 14 days and 3 month after mTBI)
  • Difference in Fractional Anisotropy (FA) between mTBI and control subjects(within 14 days and 3 month after mTBI)
  • Change of FA in mTBI subjects(from baseline within 14 days and to follow up 3 month after mTBI)
  • Difference in Mean Diffusivity (MD) between mTBI and control subjects(within 14 days and 3 month after mTBI)
  • Default mode network(within 14 days and 3 month after mTBI)
  • Change of MD in mTBI subjects(from baseline within 14 days and to follow up 3 month after mTBI)
  • Correlation of clinical symptoms and MRI measurements(within 14 days and 3 month after mTBI)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erhard Trillingsgaard Næss-Schmidt

Pathology in the brain after mTBI - A multimodal MRI study

University of Aarhus

研究点 (1)

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