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临床试验/NCT01552473
NCT01552473已完成不适用

Brain Training to Enhance Frontal Lobe Reasoning in Soldiers and Civilian Adults With TBI

The University of Texas at Dallas2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
Glasgow Outcome Scale-Extended

研究概览

简要总结

This study is being done to improve the ability to diagnose and to achieve higher-levels of functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12 months).

详细描述

In the current randomized control trial, we study the efficacy of a functionally relevant cognitive training program applied to individuals who are experiencing the effects of chronic TBI. The top-down training program labeled SMART (Strategic Memory Advanced Reasoning Training) adopts an integrative approach to train functionally relevant complex reasoning abilities (versus specific skills). This integrative approach focused on frontal lobe functions has shown promising results in a preliminary study. SMART is compared to an equally engaging education-based program labeled BHW (Brain Health Workshop). Both SMART and BHW are short-term, intensive (18 h of training over 8 weeks) group training programs that are comparable with regard to training time, amount of information, group discussions, and homework assignments. The overall goal of this trial is to examine how training integrative frontal lobe-mediated processes might improve functioning in brain injury survivors, including military service and civilian populations. We include a range of individuals with different injury types and functional abilities. We use a broad variety of assessment tools, including cognitive, neuroimaging, and functional measures, to compare the training groups.

Our overall goal is to improve the fidelity of TBI diagnoses and to achieve higher levels of functional recovery in soldiers and civilians who have suffered mild to moderate TBIs and are at the chronic stage of brain recovery. This study is also to determine the efficacy of an empirically and theoretically driven framework to enhance frontal lobe-mediated reasoning ability in individuals with TBI, given a relatively short training duration, on trained and untrained cognitive skills, on brain changes, and on measures of real-life function. Toward these aims, this trial is enrolling both soldiers and civilians with a TBI (approximately 50 mild and 50 moderate chronic TBI patients). We use cognitive tests (assessing memory, reasoning, and comprehension abilities), functional MRI scans (performing tests of cognitive function while the subject is receiving an MRI scan), and white matter maps constructed using diffusion tensor imaging (DTI) scans. The MRI scans will be used to provide biomarkers of the contributions of different brain regions to performing cognitive tasks (e.g., memory, reasoning, etc.), as well as assessments of brain efficiency, functional brain connectivity, and brain morphology. We use these measurements to gain an understanding of each individual's cognitive skills and neural measures prior to cognitive intervention. These measures also serve as indicators of the baseline function of each soldier or civilian, to be compared with after intervention, at which point they undergo post-training cognitive, MRI, and DTI assessments, enabling us to make outcome comparisons between the two different cognitive interventions. Finally, we conduct a follow-up assessment with neuropsychological and cognitive measures and neuroimaging 3 months after the interventions to assess how individuals maintain any functional changes that may occur because of the cognitive interventions.

We are targeting this intervention toward mild and moderate TBI participants, who have relatively high functioning skills. The demands of the training can be too high for some individuals falling into the more severe range, in the frequency, duration, and type of strategies and skills emphasized. We also aim to address the high level of need placed upon studies of milder TBI cases, particularly with military populations. This priority is also emphasized by the sponsoring agency, the US Department of Defense, advocating for more studies of mild TBI under the funding mechanism supporting this work.

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
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19-65 years of age
  • Sustained a traumatic brain injury at least 6 months previously
  • Comprehend simple instructions, perform tasks and take part in intervention
  • Read, speak and comprehend English
  • Participate in tasks involving motor abilities such as use of at least one arm or hand

排除标准

  • Not proficient in reading, comprehending or speaking English
  • Pre-existing Cerebral Palsy, Mental Retardation, Autism, Epilepsy, Schizophrenia, or Pervasive Developmental Disorder
  • Individuals with Psychosis, Active Behavioral Disorder, or uncontrolled epilepsy
  • Women who are pregnant

结局指标

主要结局

Glasgow Outcome Scale-Extended

时间窗: Pre-training (Baseline) Neuropsychological Test

Assesses disability after brain injury (1 dead to 8 good recovery). A higher score is a better outcome.

Community Integration Questionnaire

时间窗: Neuropsychological changes from baseline to 10 weeks post-training

To examine short-term effects of treatment on cognition and real-life outcomes relating to how successful someone is able to integrate within their community (0 lowest integration (worst outcome) to 40 maximal integration (best outcome)). A higher score is a better outcome.

Functional Status Exam

时间窗: Measure at 10 weeks post-training

To examine short-term effects of treatment on outcomes. - (0 highest function (best outcome) to 31 lowest function (worst outcome)). A lower score is a better outcome.

Daneman-Carpenter Reading Span Test

时间窗: Measure at 10 weeks post-training

Scored as 0 words to 7 words comprehended. Higher scores indicate better comprehension and thus a better outcome. Lower scores indicates a lower degree of comprehension. A higher score is a better outcome.

Hayling Sentence Completion Test

时间窗: Measure at 10 weeks post-training

To examine short-term effects of treatment on cognition by working memory. The Hayling Sentence Completion test measures response initiation (range 0 best to 30 worst). A lower score is a better outcome.

Awareness Questionnaire

时间窗: Measure at 10 weeks post-training

To examine short-term effects of treatment on real-life outcomes. This test measures impaired self-awareness after brain injury. The scale ranges from 17 (lowest self-awareness level, worst outcome) to 85 (highest self-awareness level, best outcome). A higher score is a better outcome.

次要结局

  • Network Based Statistics in Brain Connectivity(MRI measures taken at 10 weeks and 3 months post-training are combined and compared to baseline MRI yielding one number)
  • Beck Depression Inventory (BDI)(Measure taken at 10 weeks post-training)
  • Post Traumatic Stress Disorder (PTSD) Checklist(Measure taken at 10 weeks post-training)
  • Alcohol, Smoking and Substance Involvement Screening Test(Measure taken at 10 weeks post-training)
  • Alcohol Use Disorders Identification Test(Measure taken at 10 weeks post-training)
  • Digit Vigilence Test(Measure taken at 10 weeks post-training)
  • Connor-Davidson Resilience Scale(Measure taken at 10 weeks post-training)
  • Wechsler Memory Scale(Measure taken at 10 weeks post-training)
  • Wechsler Abbreviated Scale of Intelligence Vocabulary Scale(Measure taken at 10 weeks post-training)
  • Wechsler Abbreviated Scale of Intelligence Matrix Reasoning(Measure taken at 10 weeks post-training)
  • Wechsler Abbreviated Scale of Intelligence Similarities(Measure taken at 10 weeks post-training)
  • Satisfaction With Life Scale(Measure taken at 10 weeks post-training)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dan Krawczyk

Professor

The University of Texas at Dallas

研究点 (2)

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