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临床试验/NCT02692352
NCT02692352已完成不适用

Cognitive Rehabilitation of Executive Dysfunction - Goal Management Training in Patients With Acquired Brain Injury

Sunnaas Rehabilitation Hospital0 个研究点目标入组 70 人开始时间: 2012年8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
70
主要终点
Executive functioning in daily life measured by self report questionnaire

研究概览

简要总结

The main objective of this study is to examine the effect of Goal Management Training for patients with executive difficulties after acquired brain injury in a randomized controlled trial. The effect on cognitive functioning will be examined, as will the relationship between treatment effects and lesion location and size. The effect of Goal Management training on regulating emotions, quality of life and coping will be examined. The generalizability of treatment effects across etiologies will be explored by comparing effects in three patient groups; traumatic brain injury, cerebrovascular accidents and resected brain tumors. Structural Magnetic Resonance Imaging (MRI) scans and measures of white matter connectivity will be used to establish detailed lesion descriptions. Functional MRI data will provide information on the neural underpinnings of treatment related change. A secondary objective is to expand the Goal Management Training protocol with increased focus on emotional regulation and adherence to homework assignment.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Traumatic Brain Injury, stroke and resected brain tumor patients with no concomitant diseases
  • Minimum 6 months post-injury/surgery
  • Reporting executive problems by structured interview or baseline assessment (cognitive performance measures)

排除标准

  • Major psychiatric disorder or reported ongoing alcohol or substance abuse
  • Premorbid neurological disease or insult and/or comorbid neurological disease
  • Aphasia or other specified language problems causing potential communication problems
  • Impaired basic cognitive, linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with the training

结局指标

主要结局

Executive functioning in daily life measured by self report questionnaire

时间窗: one year

Behavior Rating Inventory Executive Functions Adult version

Executive functioning measured by neuropsychological assessment

时间窗: one year

Conners Continous Performance Test

次要结局

未报告次要终点

研究者

发起方
Sunnaas Rehabilitation Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sveinung Tornaas

Principal investigator

Sunnaas Rehabilitation Hospital

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