Neurorehabilitation and Functional Recovery in Multiple Sclerosis: Assessing Two Therapeutic Strategies Using Functional Magnetic Resonance Imaging.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change from baseline in Omissions
研究概览
简要总结
Multiple sclerosis (MS) is an autoimmune disease that causes cognitive and motor disabilities and contributes to decrease patients life quality. Previous results described that there are some MS patients that showed (at least in some phases of the disease) neuroplasticity processes that are able to compensate some cognitive deficits. Moreover, neuroplasticity processes seem to be limited and related to the degree of gray matter atrophy (patients with less atrophy show grater neuroplasticity than those with higher atrophy level). The aims of this project are:
- to study behavioral changes (post-training) induced by two different rehabilitation programs: a)cognitive training focused on exclusively enhancing working memory and b) aerobic + cognitive training aimed to enhance attention, working memory processes and motor capabilities using a virtual reality game.
- to study neuroplasticity changes (post-training functional connectivity changes) induced by these rehabilitation programs
- to observe the role of the atrophy in brain neuroplasticity processes.
Neuropathological status and neuroplasticity processes (studied using neuroimaging tools) as well as cognitive performance using neuropsychological tools will be assessed in a group of MS patients (with different phenotypes) at two different time points: before any training (S1) and after 10 days of training (S2). This project will be financed by the Ministerio de ciencia, innovación y universidades of the Spanish government and also have been approved by the Ethical committee of Universitat Jaume I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple Sclerosis Diagnosis.
排除标准
- •Other neurological pathologies comorbidity.
- •Magnetic resonance imaging incompatibilities.
- •Motor impairment degree that impede the task performance.
结局指标
主要结局
Change from baseline in Omissions
时间窗: Baseline and 10 training days after.
In both tasks will be assessed the number of times that a correct stimulus appear and non-response is given.
Change from baseline in Functional Connectivity in resting state
时间窗: Baseline and 10 training days after.
This is a brain activity measure during resting state through functional magnetic resonance imaging. This outcome will be assessed in both studies. fMRI sequence: T2-weighted echoplanar imaging sequence.
Change from baseline in Letters and Numbers
时间窗: Baseline and 10 training days after.
A WAIS-III subtest that measures working memory.
Change from baseline in SRT-S: Selective Reminding Test (Storing)
时间窗: Baseline and 10 training days after.
A subtest of the BRB-N (The Brief Repeatable Battery of Neuropsychological Tests for MS) which measures memory storage capacity.
Change from baseline in SRT-R: Selective Reminding Test (Retrieval)
时间窗: Baseline and 10 training days after.
This subtest of the BRB-N is a measure of memory retrieval capacity.
Change from baseline in SDMT: Symbol Digit Modalities Test
时间窗: Baseline and 10 training days after.
A BRB-N subtest which measures information processing speed.
Change from baseline in PASAT: Paced Auditory Serial Addition Task
时间窗: Baseline and 10 training days after.
A BRB-N subtest which measures working memory.
Change from baseline in Digit Span Backward
时间窗: Baseline and 10 training days after.
A WAIS-III subtest that is a working memory measure.
Change from baseline in Correct Responses
时间窗: Baseline and 10 training days after.
Number of correct responses in both tasks (n-back computerized task and balls Virtual Reality task)
Change from baseline in Reaction Time
时间窗: Baseline and 10 training days after.
This is a primary outcome of the n-back task, which refers to the amount of time (in milliseconds) that elapse from the moment the correct stimulus appears and the correct response is given.
Change from baseline in Errors
时间窗: Baseline and 10 training days after.
The number of times that a distractor stimulus appears and a response is given.
Change from baseline in Functional Connectivity in task performance
时间窗: Baseline and 10 training days after.
This is a brain activity measure during a task performance through functional magnetic resonance imaging. This outcome will be assessed in Virtual Reality study. fMRI sequence: T2-weighted echoplanar imaging sequence.
Change from baseline in SPART-D: Spatial Recall Test (Delayed)
时间窗: Baseline and 10 training days after.
This BRB-N subtest measures the spatial delayed memory.
Change from baseline in Semantic Fluency
时间窗: Baseline and 10 training days after.
A language measure that assesses semantic fluency.
Change from baseline in SRT-D: Selective Reminding Test (Delayed)
时间窗: Baseline and 10 training days after.
This BRB-N subtest measures the delayed memory.
Change from baseline in SPART: Spatial Recall Test
时间窗: Baseline and 10 training days after.
A subtest of the BRB-N that measures spatial memory.
Change from baseline in Phonemic Fluency
时间窗: Baseline and 10 training days after.
A language measure that assesses phonemic fluency.
Change from baseline in Digit Span Forward
时间窗: Baseline and 10 training days after.
A subtest of the Wechsler Adult Intelligence Scale (WAIS-III) that is an attention measure.
次要结局
- Brain Parenchymal Fraction (BPF)(Baseline)
- Cortical Lesions(Baseline)
- Lesion Volume in white matter tissue(Baseline)
- Total Intracranial Volume (TIV)(Baseline)
- Cortical Thickness(Baseline)