跳至主要内容
临床试验/NCT00715052
NCT00715052已完成不适用

The Effect of Hyperbaric Oxygen Therapy on Patients Suffering From Neurologic Deficiency Due Traumatic Brain Injury

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008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
2
主要终点
Neurologic evaluation

研究概览

简要总结

Traumatic brain injuries (TBI) are a major cause of morbidity and mortality worldwide. Due to improvements in emergency medical care, transportation and specialized trauma facilities, the number of people surviving TBI with impairment has significantly increased in recent years. The long term cognitive sequelae, which are often not visible persist far beyond the resolution of the obvious physical disabilities. This combined with the relatively low awareness of the general public has designated TBI as the "silent epidemic" (TBI CDC 2006). Hyperbaric oxygen therapy (HBOT) has been suggested as a possible treatment modality for these cases and preliminary studies are promising.

The purpose of this study is to evaluate the effectiveness of HBOT in the treatment of chronic mild traumatic brain injuries (mTBI). Sequential SPECT scans of the brain and neurocognitive testing will be used to evaluate cerebral blood flow (CBF) response, cognitive and functional improvement following treatment.

详细描述

INTRODUCTION Traumatic brain injuries (TBI) are a major cause of morbidity and mortality worldwide. Due to improvements in emergency medical care, transportation and specialized trauma facilities, the number of people surviving TBI with impairment has significantly increased in recent years. The long term cognitive sequelae, which are often not visible persist far beyond the resolution of the obvious physical disabilities. This combined with the relatively low awareness of the general public has designated TBI as the "silent epidemic" (TBI CDC 2006). Hyperbaric oxygen therapy (HBOT) has been suggested as a possible treatment modality for these cases and preliminary studies are promising.

The purpose of this study is to evaluate the effectiveness of HBOT in the treatment of chronic mild traumatic brain injuries (mTBI). Sequential SPECT scans of the brain and neurocognitive testing will be used to evaluate cerebral blood flow (CBF) response, cognitive and functional improvement following treatment.

Traumatic brain injuries (TBI) Traumatic brain injuries are a major cause of morbidity and mortality leading to major long term consequences on both a personal and national level with an estimated 5.3 million Americans suffering from permanent TBI related disabilities (24).The prevalence of traumatic brain injury in the United States is estimated to be approximately 1.5 million individuals per year (24,25). This however does not include those individuals who did not receive care in a facility included in national surveillance systems or received no medical care at all and thus probably significantly underestimates the actual number of TBI victims. The 2006 NIH consensus states a prevalence of 2.5 - 6 million people per year suffer form TBI(23).

Due to improvements in emergency medical care, transportation and specialized trauma facilities, the number of people surviving TBI with impairment has significantly increased in recent years. The long term consequences of TBI are vast, affecting a large number of people with a substantial effect on the patients themselves, their families and society as a whole. These injuries also impart a significant economic burden on those involved, both personally and as a society. Approximately 80,000 - 90,000 individuals suffer from long term disabilities annually, and the estimated costs including both direct medical care and indirect expenses such as lost earning potential were over 60 million dollars in 2001 in the US (28).

The long term sequelae of TBI may include impairment of the individuals physical, cognitive and psychosocial functioning. The neurological consequences are numerous and complex affecting various sites and functions. Sensory, motor and autonomic systems may all be affected and symptoms may include headaches, seizures, visual defects, movement disorders and sleep disorders. The cognitive consequences likewise are broad and varied. Amongst the symptoms most commonly noted are memory deficits and problems with attention and concentration. There may be impaired executive function, problem solving abilities and language difficulties as well as problems with planning, information processing, judgment and insight. While some of these symptoms may be apparent immediately after the injury, others may present days, weeks or months after the initial trauma(Kushner,24). Moreover, there can be vast fluctuations and changes in the severity and presentation over time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • TBI patients age 16 or older who are at least one year post injury with stable cognitive deficits will be recruited

排除标准

  • Had been treated with HBOT for any indiction prior to their inclusion.
  • Have any other indication for HBOT
  • Chest pathology incompatible with pressure changes
  • Inner ear disease
  • Patients suffering from claustrophobia.
  • Inability to give written informed consent by the patient or his trustee.

结局指标

主要结局

Neurologic evaluation

时间窗: 2 and 4 months

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (2)

Loading locations...

相似试验