Cognitive Improvement Through Transcranial Direct Current Stimulation for Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reaction Times in symbol-digit modalities test.
研究概览
简要总结
Multiple sclerosis (MS) is a chronic inflammatory disease with around 200.000 patients in Germany. Besides physical symptoms, cognitive resources degrade over the years. Transcranial direct current stimulation (tDCS) is an established procedure to modulate cortical excitability in motor and cognitive functions. Therefore, tDCS may improve cognitive functions in patients with MS. Patients will work on a modified version of the symbol digits modalities test in two experimental sessions. During the task, they will receive either active stimulation or sham stimulation in a crossover design. Active stimulation is divided in anodal and cathodal stimulation. Anodal stimulation should facilitate cognitive processing; cathodal stimulation, on the other hand, should hinder cognitive processing.
详细描述
Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease characterized by a multitude of symptoms, which greatly reduce the quality of life of patients. In addition to sensory and visual sensory disorders, movement disorders, paresis, fatigue and other physical symptoms, 65-95% of patients with MS also suffer from cognitive impairments. These cognitive impairments develop in the later course of the disease and express themselves in slower processing speed, delays in learning and memory performance, and executive dysfunction. In recent years, non-pharmacological approaches aimed at improving cognitive performance in MS have increasingly come into focus, including the transcranial direct current stimulation (tDCS).
TDCS has only been investigated in a few studies that had the aim to improve cognitive performance in MS. Further, it has only been carried out in combination with cognitive training paradigms and repeated stimulation sessions. Mattioli and colleagues (2016) could e.g. show that after 10 sessions of cognitive training with tDCS stimulation of the dorsolateral prefrontal cortex, there was greater improvement in symbol-digit modalities test (SDMT) in the experimental group than in the control group. Similarly, Charvet and colleagues (2018) showed that after 10 sessions of cognitive training with simultaneous tDCS stimulation of the dorsolateral prefrontal cortex, the experimental group showed a significant improvement in the domains of attention and response variability compared to the control group. These studies therefore reflect an interaction between cognitive training and tDCS, and do not allow any conclusions to be drawn about the effect of tDCS on specific processes. It is not yet known whether tDCS alone can positively influence specific cognitive functional impairments.
Therefore, the present study wants to investigate whether acute application of tDCS can improve specific cognitive functions. An adapted version of the clinically SDMT was conducted, as this test is one of the most widely used tests to describe cognitive impairments in MS. Based on a meta-analysis by Silva and colleagues (2018), that shows which brain areas are related to the implementation of the SDMT, the parietal cortex (BA7) is stimulated bilaterally with either excitatory (anodal) or inhibitory (cathodal) tDCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and investigators are blinded according to the sham / active stimulation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of multiple sclerosis.
- •no acute inflammation during the last 3 months before the experimental intervention.
- •no cortisol treatment during the last 3 months before the experimental intervention.
- •stable medication during the experimental intervention.
- •unrestrained or corrected visual ability.
- •ability to read and write short german sentences.
- •adequate motor ability to give responses on a keyboard.
- •German as main language.
排除标准
- •major depressive symptoms or any further neurological and/or psychiatric disease at experimental intervention.
- •standard tDCS exclusion criteria (e.g. cardiac pacemaker, metal implants in head region, etc.)
研究组 & 干预措施
Anodal transcranial direct current stimulation
Patients will be bilaterally stimulated with anodal tDCS at the parietal cortex (Brodmann Area 7).
干预措施: Active transcranial direct current stimulation (Device)
Cathodal transcranial direct current stimulation
Patients will be bilaterally stimulated with cathodal tDCS at the parietal cortex (Brodmann Area 7).
干预措施: Active transcranial direct current stimulation (Device)
Sham transcranial direct current stimulation for anodal group
Patients will be bilaterally stimulated with sham tDCS at the parietal cortex (Brodmann Area 7). As a consequence of the crossover design, both experimental arms receive sham stimulation.
干预措施: Sham transcranial direct current stimulation (Device)
Sham transcranial direct current stimulation for cathodal group
Patients will be bilaterally stimulated with sham tDCS at the parietal cortex (Brodmann Area 7). As a consequence of the crossover design, both experimental arms receive sham stimulation.
干预措施: Sham transcranial direct current stimulation (Device)
结局指标
主要结局
Reaction Times in symbol-digit modalities test.
时间窗: Assessed at two timepoints (1x during active (anodal/cathodal) tDCS intervention at Day 1 or 7 (depends on randomization), 1x during sham tDCS intervention at Day 1 or 7 (depends on randomization))
Reaction times in milliseconds for the performance of the symbol-digit modalities test.
次要结局
- Baseline performance in symbol-digit modalities test.(Assessment at baseline (Day 0, before stimulation).)
- Hit Rate in symbol-digit modalities test.(Assessed at two timepoints (1x during active (anodal/cathodal) tDCS intervention at Day 1 or 7 (depends on randomization), 1x during sham tDCS intervention at Day 1 or 7 (depends on randomization)))