Cognitive Rehabilitation in Sickle Cell Disease
2014年8月19日 更新者:Duke University
Cognitive Rehabilitation of Children With Sickle Cell Disease: A Pilot Study
The majority of school-age children with sickle cell disease (SCD) experience neurocognitive deficits, even in the absence of stroke.
In particular, deficits in attention and working memory have emerged as two of the most common neurocognitive sequelae of SCD.
Thus, the goal of the present proposal is to address feasibility and compliance of a novel computerized cognitive training program, Cogmed.
Pilot data will also be collected to establish preliminary efficacy.
Twenty-four children meeting initial age and diagnostic criteria will be identified and approached about participation by their attending physician during regularly-scheduled SCD clinic visits.
Baseline assessments will include a brief measure of intellectual functioning, a brief cognitive testing battery evaluating processing speed and working memory, in addition to questionnaires regarding behavior and quality of life.
Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist control (n=12).
Participants enrolled in the computerized CT program will be asked to complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week).
Following completion of the program, children and their parents will be asked to return to clinic for a follow-up visit.
After a five to eight-week waiting period, children in the waitlist condition will also be asked to return to clinic for a second visit.
Following this assessment, participants initially enrolled in the waitlist will be offered an opportunity to participant in the intervention.
If interested, they will follow the same intervention protocol described above.
These children will return to clinic for a third visit following completion of the intervention.
Compliance rate and its confidence interval will be calculated for the overall study population.
A t-test for binomial proportion with continuity correction will be used to examine whether the compliance rate is lower than the target.
Participants' change in criterion outcomes will be evaluated (i.e., those neurocognitive measures such as attention, executive functioning and working memory, that are most closely related to the trained tasks).
研究概览
研究类型
介入性
注册 (实际的)
18
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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North Carolina
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Durham、North Carolina、美国、27705
- Duke Child and Family Study Center
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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
8年 至 16年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 1) Children with a diagnosis of SCD (all genotypes)
- 2) a T-score ≥75th percentile on either the Metacognition or Executive Composite of the BRIEF; and/or
- 3) a standard score ≥1 standard deviation below the mean (<90) on the tasks of executive function or WM from the Cogstate (mean=100; SD=10)
Exclusion Criteria:
- 1) Estimated IQ ≤ 75), or motor, visual, or auditory handicap that prevents computer use;
- 2) a diagnosis of depression or a pervasive developmental disorder (by history);
- 3) clinical stroke (via record medical history); or
- 4) non-English fluency.
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:随机化
- 介入模型:交叉作业
- 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:Cogmed
These children are enrolled in the Cogmed intervention.
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Computer based program that aims to improve children's memory, attention, and processing speed.
其他名称:
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无干预:Waitlist
These children are enrolled in a waitlist condition, after which they will be offered the opportunity to complete the intervention.
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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 |
---|---|---|
Feasibility
大体时间:Post-study - Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
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Feasibility is defined as 75% of subjects completing 80% of the training program.
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Post-study - Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Efficacy
大体时间:Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
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Efficacy will be defined by participant performance on cognitive outcome measures including executive functioning outcomes from the Cogstate.
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Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Acceptance
大体时间:After the recruitment period has been completed (approximately 2-years)
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Acceptance is defined by 50% of those approached are able to participate/consent to the study.
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After the recruitment period has been completed (approximately 2-years)
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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。
调查人员
- 首席研究员:Melanie J Bonner, PhD、Duke University
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
2012年10月1日
初级完成 (实际的)
2014年7月1日
研究完成 (实际的)
2014年7月1日
研究注册日期
首次提交
2013年2月14日
首先提交符合 QC 标准的
2013年2月15日
首次发布 (估计)
2013年2月18日
研究记录更新
最后更新发布 (估计)
2014年8月20日
上次提交的符合 QC 标准的更新
2014年8月19日
最后验证
2014年8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.
Cogmed的临床试验
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University of HawaiiNational Institute on Drug Abuse (NIDA); University of Maryland, Baltimore未知
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Radboud University Medical CenterNetherlands Organisation for Scientific Research完全的
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Cambridge Memorial HospitalUniversity of Waterloo终止
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Boston Children's HospitalThrasher Research Fund; The Children's Heart Foundation完全的
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Université du Québec a MontréalUniversité de Sherbrooke; Université de Montréal; Paris West University Nanterre La Défense完全的
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Boston Children's HospitalUnited States Department of Defense完全的