Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Symbol-Digit Modalities Test
研究概览
简要总结
The purpose of this research study is to investigate the effectiveness of a technique designed to improve processing speed (i.e. the amount of time it takes to process information) in a Traumatic Brain Injury (TBI) population. The study is designed to study how well this technique can help people with TBI increase their processing speed and their ability to function better in everyday life.
详细描述
The current proposal is designed to apply this treatment protocol to a large sample of individuals with moderate to severe TBI with documented impairment in PS. The goals of the trial are to (a) test the efficacy of this treatment protocol within a TBI population, (b) evaluate the impact of the treatment on everyday functioning, (c) evaluate the longer-term efficacy of the treatment, and (d) examine the utility of booster sessions in facilitating longer-term treatment effects. Individuals with moderate to severe TBI, with documented impairment in PS, will be randomly assigned to a treatment group or a control group. Both groups will undergo baseline, immediate post-treatment and long-term follow-up assessment consisting of: (1) a standardized neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. This design will allow us to assess the efficacy of SPT in persons with TBI and evaluate its impact on everyday life.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Traumatic Brain Injury or Mild cognitive impairment
- •Fluent in English
- •processing speed impairment
排除标准
- •prior stroke or neurological disease
- •currently taking steroids and/or benzodiazepines
- •history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or pyschosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
- •significant alcohol or drug abuse history
结局指标
主要结局
Symbol-Digit Modalities Test
时间窗: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Change in scores on standardized neuropsychological tests of Processing Speed using Symbol-Digit Modalities Test
次要结局
- TBI Quality of Life, Total Score(Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention)
- TBI Quality of Life, Depression scale(Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention)
- Perceived Deficits Questionnaire(Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention)
研究者
Nancy Chiaravalloti
Director, Neuropsychology & Neuroscience; Director, Traumatic Brain Injury Research
Kessler Foundation