跳至主要内容
临床试验/NCT02482571
NCT02482571已完成不适用

Metabolic Changes in the Activated Human Visual Cortex During Mild Hypoxia

University of Minnesota1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年8月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Change in Glutamate Concentration During a Visual Stimulus Measured by Functional MRS at Hypoxia

研究概览

简要总结

The primary objective of this research is to measure changes in neurochemical concentrations during stimulation of the primary visual cortex, in both conditions of normoxia (normal oxygen availability) and induced mild hypoxia (reduced oxygen availability).

详细描述

The goal is to determine the effect of mild hypoxia on human brain energy metabolism of healthy young adult subjects. For this purpose, the Investigator will utilize non-invasive imaging modalities based on functional magnetic resonance spectroscopy (fMRS) to estimate metabolic changes during a visual stimulus, while subjects are exposed to well-controlled gas mixtures that resembles conditions of either normoxia or mild hypoxia. Identifying the impact of mild hypoxia on functional brain energy metabolism in the healthy human brain is a crucial step for generating hypotheses in multiple patient populations that experience mild hypoxia as consequence of their pathological condition, such as in sleep apnea and traumatic brain injury. The Investigator hypothesize that the energetic demands of neuronal activation as revealed by fMRS will not be affected by mild hypoxia.

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 40 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Those volunteers who are evaluated as normal and not met

排除标准

  • •will be potential candidates for this study.
  • •Exclusion Criteria:
  • •Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.).
  • •Subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
  • •Subjects that exhibit noticeable anxiety and/or claustrophobia.
  • •Subjects who cannot adhere to the experimental protocol for any reason.
  • •Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
  • •Subjects who have known conditions which can lead to emergency medical care.
  • •Been diagnosed by a physician as having a psychiatric disorder, substance abuse, neurological, cardiovascular.
  • •Been diagnosed by a physician as having respiratory diseases.
  • •Had a brain tumor or stroke.
  • •Started taking chemotherapy or immunomodulatory agents, or had any radiation treatment that could affect the brain.
  • •Had two or more seizures, or been given a diagnosis of epilepsy.
  • •Gotten a non-removable piercing or permanent eyeliner.
  • •Had a head injury that caused you to lose consciousness for more than 30 minutes or have amnesia for more than 24 hours.
  • •Anyone with a history of sleep apnea or head trauma that may have caused Traumatic Brain Injury (TBI).
  • •Gotten some type of metal in your body, either from a medical procedure or an injury.
  • •Male subjects with long beard which wouldn't allow a complete seal between the mask and the face.
  • •Anyone who is not able to see long distance without glasses or contacts.

研究组 & 干预措施

Mild Hypoxia

Experimental

Subjects are exposed to an intervention that controls the composition of breathed air by using a gas blender (RespirAct). Subjects undergo MRI and MRS while breathing air with both normal oxygen concentration (normoxia) and reduced oxygen concentration (mild hypoxia).

干预措施: Mild Hypoxia (Device)

结局指标

主要结局

Change in Glutamate Concentration During a Visual Stimulus Measured by Functional MRS at Hypoxia

时间窗: Baseline and Visual Stimulation at 4 minutes

Relative change in glutamate concentration from rest to visual stimulation as measured by fMRS (with water suppression) in the primary visual cortex during conditions of hypoxia.

Change in Glutamate Concentration During a Visual Stimulus Measured by fMRS at Normoxia

时间窗: Baseline and Visual Stimulation at 4 minutes

Relative change in glutamate concentration from rest to visual stimulation as measured by fMRS (with water suppression) in the primary visual cortex during conditions of normoxia.

次要结局

  • Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Normoxia(Baseline and Visual Stimulation at 30 seconds)
  • Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Hypoxia(Baseline and Visual Stimulation at 30 seconds)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验