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临床试验/NCT02305212
NCT02305212已完成不适用

Applying Cogmed to Improve Working Memory Abilities After Traumatic Brain Injury

Kessler Foundation4 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年12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
12
试验地点
4
主要终点
Change in scores on standardized tests of working memory

研究概览

简要总结

This study will examine a cognitive rehabilitation protocol targeted at working memory deficits for adults and children with Traumatic Brain Injury (TBI). In this randomized clinical trial, the efficacy of Cogmed, a cognitive rehabilitation protocol designed to improve working memory, will be examined in children with TBI. Neuropsychological and daily life functioning will be measured. Participants will be children (N=20) and adults (N=20) with a documented history of TBI. Participants will be randomized to a treatment group or a wait list control group. The Experimental Group will receive the Cogmed working memory training program 30-40 minutes per day, 5 days a week for 5 weeks for a total training time of approximately 15 hours. The Control Group will be a wait list control group that will cross over into treatment after the follow-up assessment. All subjects will undergo repeat assessments following completion of the working memory training protocol after the 7th week and again at 13 weeks to document changes in working memory performance.

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
9 Years 至 59 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • History of Traumatic Brain Injury

排除标准

  • Diagnosis of other neurological conditions

结局指标

主要结局

Change in scores on standardized tests of working memory

时间窗: Three points in time: Baseline assessment, Week 7 and Week 13

Measured via standardized neuropsychological tests (i.e. paper and pencil testing)

次要结局

  • Change in scores on self report measures of quality of life, assessed via questionnaire(Three points in time: Baseline assessment, Week 7 and Week 13)
  • Change in scores on self report measures of memory functioning, assessed via questionniare(Three points in time: Baseline assessment, Week 7 and Week 13)
  • Change in scores on self report measures of emotional functioning, assessed via questionnaire(Three points in time: Baseline assessment, Week 7 and Week 13)

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

Kessler Foundation

研究点 (4)

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Cogmed for Working Memory After TBI | 临床试验