Electrical Brain Stimulation for Improving Mental Health and Cognitive Functioning in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Multiple Sclerosis Impact Scale (MSIS-29)
研究概览
简要总结
Multiple Sclerosis (MS) is an autoimmune disease associated with physical disability, psychological impairment, and cognitive dysfunction. As a result, the disease burden is high, and treatment options are limited. In this randomized, double-blind study, the investigators planned to use repeated electrical stimulation and assess mental health-related variables (e.g., quality of life, sleep, psychological distress) and cognitive dysfunction in patients with MS.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of MS according to the diagnostic criteria for multiple sclerosis: 2010 Revisions to the McDonald criteria (Polman et al., 2011), certified by a professional neurologist
- •being 25-55 years old
- •providing written informed consent
- •If female, a negative urine pregnancy test
- •stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment and during the experiment
- •right handed
排除标准
- •alcohol or substance dependence
- •history of seizure
- •history of other neurological disorders than MS
- •history of head injury
- •presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces.
研究组 & 干预措施
sham tDCS group
The patients in this group receive 10 daily sessions of 1.5-mA sham transcranial direct current stimulation (tDCS).
干预措施: transcranial direct current stimulation (Device)
active tDCS group
The patients in this group receive 10 daily sessions of 1.5-mA transcranial direct current stimulation (tDCS) targeting the left lateral prefrontal cortex and right orbitofrontal cortex with anodal and cathodal stimulation respectively.
干预措施: transcranial direct current stimulation (Device)
tDCS with cognitive rehabilitation group
The patients in this group receive 10 daily sessions of 1.5-mA transcranial direct current stimulation (tDCS) followed by a 30-minute cognitive training intervention.
干预措施: transcranial direct current stimulation combined with cognitive training (Device)
结局指标
主要结局
Multiple Sclerosis Impact Scale (MSIS-29)
时间窗: up to 1 day after the intervention
The MSIS-29 is a questionnaire that comprises of 29 questions. The initial 20 questions are related to the physical impact, whereas the last 9 questions focus on the psychological impact. Each question is rated on a scale of 1 to 5, where 1 indicates "not at all" and 5 indicates "extremely". There are five response options available for the respondents to choose from.
Mini sleep questionnaire (MSQ)
时间窗: up to 1 day after the intervention
The Mini Sleep Questionnaire (MSQ) is used to screen for sleep disturbances in clinical populations. It consists of 10 items, each scored on a seven-point Likert scale ranging from "never" to "always". The questionnaire measures insomnia and oversleeping, with a high score indicating excessive sleepiness and a low score indicating insomnia.
and Depression Anxiety Stress Scale-21 (DASS-21)
时间窗: up to 1 day after the intervention
The DASS-21 is a tool used to assess the severity of symptoms related to depression, anxiety, and stress in individuals who have not been diagnosed before. The assessment has three scales, and responses to each are measured on a four-point Likert scale, ranging from 0 to 3.
次要结局
- psychomotor speed task(up to 1 day after the intervention)
- attention / vigilance task(up to 1 day after the intervention)
研究者
Mohammad Ali Salehinejad, PhD
Principal Investigator
The National Brain Mapping Laboratory (NBML)