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临床试验/NCT01978574
NCT01978574已完成不适用

A Randomized Controlled Trial of Intellectual Enrichment to Build Cognitive Reserve in Multiple Sclerosis

Kessler Foundation2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2013年6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
9
试验地点
2
主要终点
Change from Baseline in Hopkins Verbal Learning Test and Brief Visuospatial Memory Test, Total Learning and Delayed Recall

研究概览

简要总结

Cognitive problems are a primary concern for people with multiple sclerosis. In many cases, people with MS report these issues to be more debilitating than the motor symptoms that are targeted by most treatment strategies. For people with MS, impaired memory and thinking skills can interfere with the ability to function efficiently in multiple professional and personal roles. Finding ways to decrease, slow, or reverse declines in memory and thinking skills is a vitally important research priority. We now know that engaging in intellectually enriching activities helps protect against the negative impact of MS disease-related declines in memory and thinking. Such activities contribute to something called 'cognitive reserve,' which serves as a protection against disease-related declines in memory and thinking. Thus far, no one has created a treatment that aims to provide a concentrated 'dose' of intellectual enrichment to build cognitive reserve. The present intervention aims to do precisely this. Here, we have developed a program of enriching activities that are delivered via a personal iPad. This allows for a 12-week 'treatment' that is entirely home-based, while also providing close personal contact between participants and our study personnel, who will communicate daily via emails. Week by week, participants choose from a menu of intellectually enriching activities such that their treatment is dynamic and customizable to fit their interests. The intervention is designed to be fun, as we hope the activities will be incorporated into people's lives beyond the period of the study itself. Given what we already know about the striking benefits of cognitive reserve to protect against disease-related declines in cognitive functioning, we expect to show that treatment with a daily, intense, intellectually enriching schedule of activities results in improved thinking and memory for people with MS. We will also investigate the positive impact of our treatment on the brains of people with MS through brain scans. We expect to see evidence for a shift toward more efficient processing in the brain, changes that translate to improved memory and thinking skills.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 25-65
  • MS duration >5 years
  • read and speak English fluently

排除标准

  • currently experiencing an MS exacerbation
  • MS exacerbation within 6 weeks of study start
  • left handed
  • non-MRI compatible: metal in body, claustrophobic
  • history of neurological disorder other than MS
  • history of head injury
  • history of schizophrenia or bipolar disorder
  • currently taking steroids, benzodiazepines, and/or neuroleptics
  • do not speak English as primary language

结局指标

主要结局

Change from Baseline in Hopkins Verbal Learning Test and Brief Visuospatial Memory Test, Total Learning and Delayed Recall

时间窗: Baseline and 13 weeks

次要结局

  • Change from Baseline in Beck Depression Inventory(Baseline and 13 weeks)

研究者

发起方
Kessler Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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