跳至主要内容
临床试验/NCT02745210
NCT02745210终止不适用

Non-invasive Clinical Imaging of Cerebral Metabolism Following Brain Injury Using 13C Magnetic Resonance Spectroscopy

Loma Linda University0 个研究点目标入组 9 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
9
主要终点
Detection of 13C Enriched Cerebral Metabolites

研究概览

简要总结

Despite the decline in fatal traumatic brain injury (TBI) incidence in recent years, TBI morbidity remains a public health challenge and is the leading cause of disability in the United States. Detailed knowledge of the metabolic alterations following TBI will provide a significant advancement to our understanding of the hypometabolic response to TBI, which is key information for the future development and testing of novel therapeutic interventions that by-pass or compensate for the metabolic dysfunction.

The goal of this study is to determine the clinical utility of in vivo 13C MRS to identify specific metabolic alterations following TBI. We hypothesize that following TBI, metabolic pathways are altered causing an incomplete oxidative of glucose in neurons and astrocytes resulting in a decrease in cerebral metabolism.

详细描述

Despite the decline in fatal traumatic brain injury (TBI) incidence in recent years, TBI morbidity remains a public health challenge and is the leading cause of disability in the United States To combat these effects, new research is needed to identify mechanisms of injury that will lead to potential targets for therapeutic interventions that improve neurological outcome. One promising area of research is the cerebral metabolic dysfunction following TBI. Studies of post-traumatic cerebral metabolism have shown that cerebral metabolic rate of glucose (CMRglc) decreases for a period of days, weeks or months after injury with the duration and degree of hypometabolism correlating to level of consciousness and a strong predictor of long-term neurological outcome. However, specific changes in intermediary carbohydrate metabolic pathways have not yet been identified. In addition, the role of astrocyte metabolism in the post-injury metabolism has not been studied. This study uses in vivo 13C magnetic resonance spectroscopy (MRS) at 3 Tesla, a novel method in the clinical study of TBI, to non-invasively study the metabolic fate and flux of glucose (metabolized in both neurons and astrocytes) and acetate (metabolized in astrocytes) through metabolic pathways during the hypometabolic period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

入选标准

  • Subjects will be at least 18 years of age without gender or ethnic restrictions.
  • Severe accidental TBI defined as the lowest post-resuscitation GCS < 8 prior to administration of sedatives or paralytics.
  • Eligibility for MRI per routine screening checklist.

排除标准

  • History of neurosurgical intervention, excluding the placement of ventriculostomy shunt
  • History of a prior known brain injury with associated loss of consciousness.
  • History of a known neurological disorder prior to qualifying injury.
  • History of psychiatric disorder.
  • History of diabetes or current unstable serum glucose level.
  • Renal insufficiency or known history of kidney disease.
  • Known contraindication to MRI such as, pacemaker, pregnancy, and/or other non-MR compatible implanted device.

结局指标

主要结局

Detection of 13C Enriched Cerebral Metabolites

时间窗: 5 years

Direct detection, localized in vivo 13C MRS will be used to measure the 13C enrichment of glutamate and glutamine following an infusion of 30% isotopically enriched \[1-13C\] glucose and \[1, 2-13C2\] acetate.

次要结局

未报告次要终点

研究者

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

Brenda Bartnik Olson, PhD

Principal Investigator

Loma Linda University

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