跳至主要内容
临床试验/NCT01838811
NCT01838811已完成不适用

Applying Speed of Processing Training (SPT) to Individuals With TBI

Kessler Foundation2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Processing Speed Performance

研究概览

简要总结

This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Traumatic Brain Injury (TBI), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. This study will (1) apply a treatment protocol for PS impairments, well-validated in aging, to persons with TBI with impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess the effectiveness of the intervention utilizing global measures of daily life, including an objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in that it will be the first to evaluate the efficacy of a highly-manualized structured behavioral treatment for processing speed deficits in persons with TBI utilizing the optimal methodology for carrying out such studies, a randomized clinical trial. Given the prevalence of PS deficits in the TBI population and the significant impact such deficits have on everyday functioning, public safety, and overall quality of life, the identification of an effective intervention for PS deficits in TBI could have a profound impact on the population and society as a whole.

研究设计

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

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

  • fluent in English
  • processing speed impairment (based on evaluation).

排除标准

  • currently taking steroids and /or benzodiazepines
  • prior stroke or neurological disease
  • history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
  • significant alcohol or drug abuse history

结局指标

主要结局

Processing Speed Performance

时间窗: week 6 and week 12

Neuropsychological tests which measure processing speed will be used to determine whether there has been a change in performance.

次要结局

未报告次要终点

研究者

发起方
Kessler Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Chiaravalloti

Director, Neuropsychology & Neuroscience Lab

Kessler Foundation

研究点 (2)

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