Testing the Feasibility of Computer-based Cognitive Training in Individuals with Multiple Sclerosis Living in the Community
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- California Learning Verbal Test III
研究概览
简要总结
Cognitive impairments are common in multiple sclerosis (MS) diagnosed both at the onset and throughout the disease course. Poor cognitive abilities have been associated with poor outcomes such as higher levels of unemployment, poor quality of life, driving difficulties among others. Learning and memory are a common cognitive deficit. This computer-based cognitive training is a 10-session treatment proven to be effective in ameliorating learning and memory in individuals with MS across 3 realms of functioning: objective cognitive performance, daily life activities and neuroimaging. Despite this strong efficacy, as well as the recent clinical application of this computer-based cognitive training across the world, recent in-person studies have highlighted that transportation to the clinic to complete treatment sessions is a significant obstacle to clinical use of this effective treatment. To address this limitation, the proposed pilot study will test the efficacy of the computer-based cognitive training administered remotely via zoom health in persons with multiple sclerosis.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English as primary language
- •Diagnosis of multiple sclerosis
排除标准
- •Most recent exacerbation within one month
- •Other Neurological History: head injury, stroke, seizures, or any other significant neurological history will not be included in the study
- •Individuals with an active diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II will be excluded from the study.
- •Poor Visual Acuity (corrected vision in worse eye < 20/60), diplopia, or nystagmus
- •Inability to understand directions and following one, two, and three step commands
- •Intact New Learning and Memory: Only individuals that show impaired performance on a memory test will be included in the study
研究组 & 干预措施
Training
Computer based cognitive training delivered remotely via Zoom Health
干预措施: Learning and memory training (Behavioral)
sham comparator
The sham comparator group will receive sham memory exercises administered on a laptop computer via Zoom Health twice a week for five weeks (10 placebo control sessions).
干预措施: Sham Comparator (Behavioral)
结局指标
主要结局
California Learning Verbal Test III
时间窗: Primary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion)
次要结局
- Ecological Memory Simulations(Secondary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion))
研究者
Silvana Costa
Research Scientist
Kessler Foundation