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临床试验/NCT02452619
NCT02452619Unknown不适用

Brain Angiogenesis Induced by Hyperbaric Oxygen Therapy Can be Visualized by Perfusion MRI in Brain Injury Patients

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Microstructure changes (DTI)

研究概览

简要总结

In our institute there is ongoing treatment of brain injury patients with Hyperbaric oxygen therapy. These patients undergo neuro-cognitive function tests in addition to brain imaging studies before and after treatment.

The aim of this study was to evaluate the perfusion and microstructure changes seen in MRI in addition to the cognitive tests before and after the treatment.

详细描述

Retrospective analysis of patients suffering from chronic neuro-cognitive damage due to TBI treated at Sagol center for hyperbaric medicine and research, Assaf Harofeh Medical Center, Israel

Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). The study was approved by the institutional review board of the hospital.

Patients are treated with 50-70 daily hyperbaric sessions, 5 days per week. Each session consists of 60 minutes exposure to 100% oxygen at 1.5 ATA.

All patients that underwent MRI before and after HBOT. The MRI protocol included DSC, DCE, DTI, FLAIR, T2 and SWI.

MRI scans sequences parameters:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT).

排除标准

  • did no complete treatment or did not complete examinations.

结局指标

主要结局

Microstructure changes (DTI)

时间窗: Before and after treatment. Treatment is approximately 3 months.

Perfusion MRI changes

时间窗: Before and after treatment. Treatment is approximately 3 months.

次要结局

未报告次要终点

研究者

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

Assaf Harofeh MC

Dr Sigal Tal

Assaf-Harofeh Medical Center

研究点 (1)

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