强化计算机化认知训练的影响 (CCT)
2026年6月22日 更新者:Kirk Daffner, MD、Brigham and Women's Hospital
计算机认知训练:预测后天性脑损伤认知增强因素的表征
调查参与强化计算机认知训练方案后预测认知增强的因素。
研究概览
详细说明
为了研究预测参加为期 6 个月、每周 5 天的强化训练后认知能力增强的因素,请使用 ABI Wellness BEARS 平台和 Brainex 软件符号关系模块。
该研究将探讨强化工作记忆训练对大脑可塑性神经认知标志物(干预相关变化)的影响,包括 1) 神经心理学测试表现,2) 血液和唾液中的 BDNF 水平,3) 工作记忆的 ERP 测量,以及 4 ) 静息态功能磁共振成像和结构磁共振成像。
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准:
- 麻省总医院布莱格姆卫生系统的患者,因至少 12 个月前持续的获得性脑损伤 (ABI) 而患有主要注意力和执行功能困难和/或诊断为轻度认知障碍或轻度神经认知障碍(非遗忘特征)来学习接触。
- 年龄25-65岁
- 英语方面很熟练
- 愿意并且能够完成 12 个月内所有与研究相关的活动,包括前往布莱根妇女医院(波士顿)进行四次现场评估以及两次血清和唾液样本采集。
- 使用带有网络摄像头和稳定互联网的计算机。
- 一位可靠的研究线人,可以在四个时间点完成一份有关参与者认知/日常功能的调查问卷。
排除标准:
- 根据 DSM-5 标准,过去 2 年内有酒精或药物滥用或依赖史。
- 潜在进行性神经退行性疾病的可能性很高。
- 中度至重度认知障碍的证据,基于简易精神状态检查 (MMSE) 得分为 21 或更低(Tombaugh & McIntyre,1992)。
- 患者健康问卷 (PHQ)-9(Kroenke 等人,2010)得分 ≥ 19,除非治疗提供者认为没有活动性抑郁症(例如,适应障碍、悲伤反应)。
- 活动性精神病症状。
- 严重的感觉丧失,使得参与者即使有很大的住宿条件也不太可能参加研究培训(自我报告阅读普通报纸印刷品极其困难或经过性能测试的矫正视力测试分数低于 20/30)。
- 沟通困难阻碍了参与者有效地参与这个高度互动的研究方案(基于采访者对一个人被理解和理解他人的能力的评级)。
- 目前正在参与药理学或其他介入研究试验。
- 预期寿命<2年。
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:计算机化认知训练
有关更多信息,请参阅干预/治疗部分。
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参与者将每周五天(M-T-W-Th-F)登录 ABI 健康平台,并使用符号关系模块进行 45 至 60 分钟的培训。
每隔一周,参与者将通过 Zoom 与培训主持人会面,审查培训进度并解决任何与培训相关的问题。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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认知结果测量的变化
大体时间:6个月
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我们将使用 NIH 工具箱总认知综合、流体智力综合的年龄校正标准分数以及 RAVLT、语言流畅性和越野任务的个人分数作为认知结果衡量标准。
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6个月
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血液和唾液中 BDNF 水平的变化
大体时间:6个月
|
使用FUJIFILM高灵敏度ELISA试剂盒和市售ELISA试剂盒。
|
6个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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自我报告锻炼和体力活动
大体时间:6个月
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老年人体力活动量表(问卷)。 测量步行、中度和剧烈活动。 零下限,无上限。 数值越高表示体力活动越多。 |
6个月
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ERP 措施中与干预相关的变化,例如 P3 部分(P3a 和 P3b)
大体时间:6个月
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1) 针对言语和视觉工作记忆任务进行测量
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6个月
|
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静息态功能磁共振成像的干预相关变化
大体时间:6个月
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群体 ICA 分析程序将应用于干预前后的 rs-fMRI BOLD 信号活动。
将探索功能磁共振成像参数、认知和训练数据之间的相关性(例如 NIH 工具箱总体认知综合、流体智力综合、结晶综合、CCT 参与和进展)。
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6个月
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生活质量自我报告
大体时间:6个月
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弗拉纳根生活质量量表(问卷)。 衡量生活质量。 李克特量表0-112,数值越高表明生活质量越高。 |
6个月
|
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睡觉
大体时间:6个月
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医疗结果研究睡眠量表(调查问卷) 李克特量表测量睡眠质量和睡眠问题指数。 0-60,数值越大代表睡眠质量越高,睡眠问题越少。 |
6个月
|
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焦虑
大体时间:6个月
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广泛性焦虑症 7 项目量表(问卷) 李克特量表测量焦虑的严重程度。 0-21,数值越大代表焦虑越严重。 |
6个月
|
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沮丧
大体时间:6个月
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患者健康问卷抑郁量表(问卷) 李克特量表测量抑郁症的严重程度。 0-24,分数越高代表抑郁症越严重。 |
6个月
|
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疲劳影响的自我报告
大体时间:6个月
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改良疲劳影响量表 李克特量表衡量疲劳对身体、认知和心理社会活动的影响。 0-84,分数越高表明疲劳对人的活动影响越大。 |
6个月
|
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关于认知/思维能力的感受
大体时间:6个月
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认知自我效能感问卷 李克特量表衡量人们对其认知/思维能力的感受。 0-72,分数越高表明对认知/思维能力的功效有更积极的感受。 |
6个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Kim C Willment, PhD、Brigham and Women's Hospital
- 首席研究员:Kirk R Daffner, MD、Brigham and Women's Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Kroenke K, Spitzer RL, Williams JB, Lowe B. The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):345-59. doi: 10.1016/j.genhosppsych.2010.03.006. Epub 2010 May 7.
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- Simon SS, Tusch ES, Feng NC, Hakansson K, Mohammed AH, Daffner KR. Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial. J Alzheimers Dis. 2018;65(3):931-949. doi: 10.3233/JAD-180455.
- Porter S, Torres IJ, Panenka W, Rajwani Z, Fawcett D, Hyder A, Virji-Babul N. Changes in brain-behavior relationships following a 3-month pilot cognitive intervention program for adults with traumatic brain injury. Heliyon. 2017 Aug 4;3(8):e00373. doi: 10.1016/j.heliyon.2017.e00373. eCollection 2017 Aug.
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- Billig AR, Feng NC, Behforuzi H, McFeeley BM, Nicastri CM, Daffner KR. Capacity-limited resources are used for managing sensory degradation and cognitive demands: Implications for age-related cognitive decline and dementia. Cortex. 2020 Dec;133:277-294. doi: 10.1016/j.cortex.2020.09.005. Epub 2020 Sep 24.
- Biswal BB. Resting state fMRI: a personal history. Neuroimage. 2012 Aug 15;62(2):938-44. doi: 10.1016/j.neuroimage.2012.01.090. Epub 2012 Jan 24.
- Buckner RL, Krienen FM, Yeo BT. Opportunities and limitations of intrinsic functional connectivity MRI. Nat Neurosci. 2013 Jul;16(7):832-7. doi: 10.1038/nn.3423. Epub 2013 Jun 25.
- Burckhardt CS, Anderson KL, Archenholtz B, Hagg O. The Flanagan Quality Of Life Scale: evidence of construct validity. Health Qual Life Outcomes. 2003 Oct 23;1:59. doi: 10.1186/1477-7525-1-59.
- Chen K, Azeez A, Chen DY, Biswal BB. Resting-State Functional Connectivity: Signal Origins and Analytic Methods. Neuroimaging Clin N Am. 2020 Feb;30(1):15-23. doi: 10.1016/j.nic.2019.09.012.
- Coulter CL, Weber JM, Scarvell JM. Group physiotherapy provides similar outcomes for participants after joint replacement surgery as 1-to-1 physiotherapy: a sequential cohort study. Arch Phys Med Rehabil. 2009 Oct;90(10):1727-33. doi: 10.1016/j.apmr.2009.04.019.
- Daffner KR, Chong H, Sun X, Tarbi EC, Riis JL, McGinnis SM, Holcomb PJ. Mechanisms underlying age- and performance-related differences in working memory. J Cogn Neurosci. 2011 Jun;23(6):1298-314. doi: 10.1162/jocn.2010.21540. Epub 2010 Jul 9.
- Kersel DA, Marsh NV, Havill JH, Sleigh JW. Neuropsychological functioning during the year following severe traumatic brain injury. Brain Inj. 2001 Apr;15(4):283-96. doi: 10.1080/02699050010005887.
- Denboer JW, Nicholls C, Corte C, Chestnut K. National Institutes of Health Toolbox Cognition Battery. Archives of Clinical Neuropsychology. 2014; 29(7): 692-694
- Hays RD, Stewart AL. Measuring functioning and well-being: The Medical Outcomes Study Approach. Duke University Press. 1992.
- Holloway M, Tasker R. The Experiences of Relatives of People with Acquired Brain Injury (ABI) of the Condition and Associated Social and Health Care Services. Journal of Long-term Care. 2019, p.99-110
- Ivnik RJ, Malec JF, Smith GE, Tangalos EG, Petersen, RC. Neuropsychological tests' norms above age 55: COWAT, BNT, MAE Token, WRAT-R Reading, AMNART, STROOP, TMT, and JLO. The Clinical Neuropsychologist. 1996; 10(3): 262-278.
- Jones JM, Haslam SA, Jetten J, Williams WH, Morris R, Saroyan S. That which doesn't kill us can make us stronger (and more satisfied with life): the contribution of personal and social changes to well-being after acquired brain injury. Psychol Health. 2011 Mar;26(3):353-69. doi: 10.1080/08870440903440699.
- Kersel DA, Marsh NV, Havill JH, Sleigh JW. Psychosocial functioning during the year following severe traumatic brain injury. Brain Inj. 2001 Aug;15(8):683-96. doi: 10.1080/02699050010013662.
- Kurasik S. Group dynamics in the rehabilitation of hemiplegic patients. J Am Geriatr Soc. 1967 Sep;15(9):852-5. doi: 10.1111/j.1532-5415.1967.tb02443.x. No abstract available.
- Ledreux A, Hakansson K, Carlsson R, Kidane M, Columbo L, Terjestam Y, Ryan E, Tusch E, Winblad B, Daffner K, Granholm AC, Mohammed AKH. Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study. J Alzheimers Dis. 2019;71(4):1245-1261. doi: 10.3233/JAD-190756.
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- Lezak MD, Howieson DB, Bigler ED, & Tranel D. Neuropsychological assessment, 5th ed. APA PsychNet. 2012.
- Nicastri CM, McFeeley BM, Simon SS, Ledreux A, Hakansson K, Granholm AC, Mohammed AH, Daffner KR. BDNF mediates improvement in cognitive performance after computerized cognitive training in healthy older adults. Alzheimers Dement (N Y). 2022 Aug 30;8(1):e12337. doi: 10.1002/trc2.12337. eCollection 2022.
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- Sevick et al. Alterations in Resting State Functional Connectivity in Patients with Traumatic Brain Injury Following a 3-month Pilot Cognitive Intervention Program. Poster Presented at: UBC Department of Psychiatry 2020 Virtual Research Day. 2020.
- Tennstedt SL, Unverzagt FW. The ACTIVE study: study overview and major findings. J Aging Health. 2013 Dec;25(8 Suppl):3S-20S. doi: 10.1177/0898264313518133. No abstract available.
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- Troyer AK, Leach L, Vandermorris S, Rich JB. The measurement of participant-reported memory across diverse populations and settings: a systematic review and meta-analysis of the Multifactorial Memory Questionnaire. Memory. 2019 Aug;27(7):931-942. doi: 10.1080/09658211.2019.1608255. Epub 2019 Apr 25.
- Tulsky DS, Kisala PA. Overview of the Spinal Cord Injury-Functional Index (SCI-FI): Structure and Recent Advances. Arch Phys Med Rehabil. 2022 Feb;103(2):185-190. doi: 10.1016/j.apmr.2021.10.006. Epub 2021 Oct 28.
- Tusch ES, Alperin BR, Ryan E, Holcomb PJ, Mohammed AH, Daffner KR. Changes in Neural Activity Underlying Working Memory after Computerized Cognitive Training in Older Adults. Front Aging Neurosci. 2016 Nov 8;8:255. doi: 10.3389/fnagi.2016.00255. eCollection 2016.
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有用的网址
- Experiences of individuals with acquired brain injury and their families interacting with community services: a systematic scoping review
- Tracking early decline in cognitive function in older individuals at risk for Alzheimer's disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function Instrument
- Capacity-limited resources are used for managing sensory degradation and cognitive demands: Implications for age-related cognitive decline and dementia
- Resting state fMRI: a personal history
- Opportunities and limitations of intrinsic functional connectivity MRI
- The Flanagan Quality Of Life Scale: evidence of construct validity
- Resting-State Functional Connectivity: Signal Origins and Analytic Methods
- Group physiotherapy provides similar outcomes for participants after joint replacement surgery as 1-to-1 physiotherapy: a sequential cohort study
- Mechanisms Underlying Age- and Performance-related Differences in Working Memory
- National Institutes of Health Toolbox Cognition Battery
- Neuropsychological functioning during the year following severe traumatic brain injury
- The Experiences of Relatives of People with Acquired Brain Injury (ABI) of the Condition and Associated Social and Health Care Services
- That which doesn't kill us can make us stronger (and more satisfied with life): the contribution of personal and social changes to well-being after acquired brain injury
- Psychosocial functioning during the year following severe traumatic brain injury
- Group dynamics in the rehabilitation of hemiplegic patients
- Differential Effects of Physical Exercise, Cognitive Training, and Mindfulness Practice on Serum BDNF Levels in Healthy Older Adults: A Randomized Controlled Intervention Study
- BDNF mediates improvement in cognitive performance after computerized cognitive training in healthy older adults
- The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review
- Modified Fatigue Impact Scale
- Changes in brain-behavior relationships following a 3-month pilot cognitive intervention program for adults with traumatic brain injury
- Resting-state brain networks: literature review and clinical applications
- Is Computerized Working Memory Training Effective in Healthy Older Adults? Evidence from a Multi-Site, Randomized Controlled Trial
- The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue
- The ACTIVE study: study overview and major findings
- The mini-mental state examination: a comprehensive review
- A comparison of the cost-effectiveness of two types of occupational therapy services
- The measurement of participant-reported memory across diverse populations and settings: a systematic review and meta-analysis of the Multifactorial Memory Questionnaire
- Overview of the Spinal Cord Injury-Functional Index (SCI-FI): Structure and Recent Advances
- Changes in Neural Activity Underlying Working Memory after Computerized Cognitive Training in Older Adults
- Rey Auditory-Verbal Learning Test: structure analysis
- Cost-effectiveness of cognitive-behavioural therapy and drug interventions for major depression
- Acquired brain injury: combining social psychological and neuropsychological perspectives
- The Physical Activity Scale for the Elderly (PASE): development and evaluation
- Group therapy utilization in inpatient spinal cord injury rehabilitation
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年10月1日
初级完成 (实际的)
2025年12月5日
研究完成 (估计的)
2026年9月1日
研究注册日期
首次提交
2023年10月30日
首先提交符合 QC 标准的
2023年11月8日
首次发布 (实际的)
2023年11月14日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月22日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.