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临床试验/NCT02634567
NCT02634567已完成不适用

Attention/Working Memory Rehabilitation in Multiple Sclerosis: A Pilot Project Using Cogmed Working Memory Training

London Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2016年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Paced Auditory Serial Addition Test

研究概览

简要总结

Patients diagnosed with any type of multiple sclerosis (MS) who show objective evidence of attention problems will be randomized to standard medical care (treatment as usual) or attention training, which will be completed at their home using a commercially available attention training task (Cogmed Working Memory Training - CWMT) for 5 weeks. Patients will undergo cognitive testing before and after intervention and at 6 months follow up.

详细描述

MS patients who meet the inclusion criteria of the study showing deficits on at least 2 of 3 attention/working measures who will then be randomized to either a treatment group (cognitive rehabilitation training) or a control group (standard clinical care). Patients must show mild to moderate-severe impairment on 2 out of 3 test measures of processing speed and sustained attention to be included in the study. Participants will undergo cognitive testing (Minimal Assessment of Cognitive Function in MS [MACFIMS] performed at Dr. Morrow's cognitive clinic at Parkwood Hospital) at pre- and post-treatment, and also at 6-months follow-up. Participants will also fill out non-cognitive measures in the form of questionnaires regarding quality of life (QoL), self-efficacy, stress, and copying strategies at both pre and post treatment. In addition, the intervention group will undergo attention training using CWMT for 5 days per week (30-45 minutes daily) for 5 weeks. They will complete this training by themselves in their home. The assigned Cogmed coach will set up the Cogmed program for the duration of the trail on the training group participant's computers. The study will not be able to continue to pay for the Cogmed program after the 5 week training sessions. Participants are welcome to purchase the software themselves after the entire study has ended if they would like at: http://www.cogmed.com/. The CWMT (Cogmed) method consists of 25 training sessions done online. Each participant assigned to the training group will complete eight exercises for five weeks with five sessions every week. The Cogmed program uses an adaptive training approach in which the difficulty level of the training is adjusted in real time (trial by trial basis) based on the trainee's performance. Each session consists of a selection of various tasks that target the different aspects of attention/working memory. Specifically, each session will involve training on visuospatial working memory tasks (e.g., remembering the position of objects in a 4 x 4 Grid) as well as verbal working memory tasks (e.g., remembering phonemes, letters, or digits). Given that adults will be involved in this study, Cogmed QM will be used, a version of the CWMT program adapted for adults. Participants will engage in weekly discussions over the phone for about 1 hour with an assigned Cogmed coach who will provide support and encouragement over the 5 weeks. Additional calls will be made if the Cogmed coaches see the participant is not completing their online training. Each participant will be assigned a Cogmed qualified coach who is responsible for providing structure, motivation, and feedback on training progress in order to optimize training gains. Before Cogmed training begins, each participant in the training group will be visited once by their respective Cogmed coach who will ensure that participants' daily Cogmed sessions will be conducted in a space in their home that is conducive to attention training (e.g., little clutter, private area of the home) and ensure consistency between participants. During training, each participant's performance will be tracked online and will be reviewed by the participant and his/her coach in weekly telephone meetings throughout the five week period. The participant's performance will be tracked online on the Cogmed platform. The Cogmed coaches set up the program for the participants and assign them a username. The Cogmed coaches can track the individual's performance and see who has completed the training based on their username. No Internet Protocol (IP) information will be collected. At the end of training, the coach will summarize the training by telephone with the participant.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Males/Females, Ages 18-64, with any type of MS
  • Lower to moderate physical disability
  • Demonstrated impaired attention/working memory on 2 of 3 measures (Patients with a z-score lower than -1.5 on at least 2 of the 3 measures will be characterized as showing attention/working memory deficits)
  • Patients must have a Mac or personal computer (PC) computer at home with access to the internet

排除标准

  • Clinical relapse/steroid treatment 1 month prior to study entry
  • Physical disability that prevents completion of study measures or training
  • History of severe mental illness or daily marijuana use
  • Those who do not meet the inclusion criteria.

研究组 & 干预措施

Treatment as Usual

No Intervention

This group will not any training with the Cogmed training program.

Training Group

Experimental

This group will receive intervention with the Cogmed training program and coach over a period of 5 weeks.

干预措施: Cogmed Working Memory Training (CWMT) (Behavioral)

结局指标

主要结局

Paced Auditory Serial Addition Test

时间窗: 7 months

Cognitive test; Change pre- to post-test between groups

Symbol Digit Modalities Test

时间窗: 7 months

Cognitive test; Change pre- to post-test between groups

Stroop colour word test

时间窗: 7 months

Cognitive test; Change pre- to post-test between groups

次要结局

  • Short Form Health Survey(7 months)
  • Hospital Anxiety and Depression Scale(7 months)
  • Fatigue Severity Scale(7 months)
  • Dysexecutive Questionnaire(7 months)
  • Cognitive Failures Questionnaire(7 months)
  • Judgement of Line Orientation(7 months)
  • Controlled Oral Word Association Test(7 months)
  • California Verbal Learning Test(7 months)
  • Brief Visual Memory Test(7 months)
  • Delis-Kaplan Executive Function System Sorting Test(7 months)
  • Beck Depression Inventory - Fast Screen(7 months)
  • BRIEF Cope(7 months)
  • Social Stress and Support Interview(7 months)
  • Multiple Sclerosis Neuropsychological Screening Questionnaire(7 months)
  • Perceived Deficits Questionnaire(7 months)
  • Visual Spatial Span Board Assessment(7 months)
  • Digit Span(7 months)
  • Arithmetic(7 months)
  • Letter-Number Sequencing(7 months)

研究者

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

Sarah Morrow

MD, MS, FRCPC (Neurology)

London Health Sciences Centre

研究点 (2)

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