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临床试验/NCT01138020
NCT01138020已完成不适用

Cognitive Rehabilitation of Blast-induced Traumatic Brain Injury

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2011年3月1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
77
试验地点
2
主要终点
Cognitive functioning

研究概览

简要总结

The purpose of this study is to investigate the efficacy of a structured rehabilitation program on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).

详细描述

The most common impairments following blast-induced traumatic brain injury (bTBI) are cognitive deficits in the domain of executive functioning, learning and memory, and functional and psychosocial disabilities that are closely related to these cognitive deficits. There are no treatment protocols available to address the multiple cognitive impairments in bTBI, but cognitive rehabilitation has proven efficacious in the treatment of non-blast TBI. The cognitive training modules the investigators plan to evaluate have improved organization and memory function in patients with non-blast TBI, but it is unknown whether their efficacy exceeds that of programs that focus only on education and support. This study is a between group comparison of a cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function, and an active control group receiving educational intervention geared at personal management of TBI-related symptoms.

研究设计

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

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) active-duty personnel or Veterans exposed to blast
  • Meets criteria for mild TBI
  • loss of consciousness (LOC) of 30 min or less
  • Age: 21- 50

排除标准

  • Evidence of penetrating head injury
  • History of previous neurological diagnosis
  • History of previous psychotic disorder prior to the blast exposure
  • Hearing or vision impairment

研究组 & 干预措施

Arm 1

Experimental

Cognitive intervention

干预措施: Cognitive Intervention (Behavioral)

Arm 2

Active Comparator

Educational intervention

干预措施: Educational intervention (Behavioral)

结局指标

主要结局

Cognitive functioning

时间窗: Ten weeks

Scaled Score on the standardized neuropsychological testing

次要结局

  • Daily functioning(Ten weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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