Effects of Non-invasive Transcranial Electrical Stimulation on Cognition in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- EVO Performance Change From Baseline Assessment
研究概览
简要总结
The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS.
详细描述
The participants' baseline cognitive function will be assessed with a tablet-based, videogame-like software specifically designed as a medical device to test and train cognitive function for populations with cognitive disorders. After baseline test assessment, participants will receive stimulation while playing the training version of the software. After the stimulation, cognitive performance will be evaluated again with the testing version. Investigators will assess changes in cognitive performance associated with stimulation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-65,
- •diagnosis of MS
- •Expanded Disability Status Scale (EDSS)≤6.5, no paresis of the upper limbs
- •a minimum of 3 months since the last relapse
- •Beck Depression Inventory<19
- •normal hearing
- •and no changes in MS or symptomatic medications in past 2 months
排除标准
- •prior brain surgery
- •clips in brain
- •epilepsy or other neurological or non-affective psychiatric disorders
- •pregnancy
结局指标
主要结局
EVO Performance Change From Baseline Assessment
时间窗: Baseline (pre-stim) and post-stimulation, up to 2 hours
EVO tool is a digital cognitive assessment developed to assess cognitive function including attention and related cognitive control processes in clinical populations. It comes with the closed-loop adaptive algorithm which makes proportional changes in gameplay difficulty when the participant's performance deviates from an 80% rate of accuracy, which ensures that task difficulty is equated across participants and enhances engagement. Gameplay threshold (level 0 to level 20), response time and response time variability will be measured to evaluate attention control. Higher threshold level, lower response time and smaller response time variability indicate improvement.
Processing Speed Change From Baseline Assessment
时间窗: Baseline (pre-stim) and post-stimulation (up to 2 hours)
Symbol Digit Modalities Test (SDMT) score will be used to measure processing speed. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening.
次要结局
未报告次要终点