The Effect of Home-Based Transcranial Direct Current Stimulation on Fatigue in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Tiredness
研究概览
简要总结
The available therapeutic strategies for Multiple Sclerosis (MS)-related symptoms are usually faced with limited efficacy and numerous side effects. Patients with MS frequently suffer from fatigue, affective symptoms, and cognitive deficits.
详细描述
For these reasons, non-invasive brain stimulation (NIBS) techniques, namely transcranial direct current stimulation (tDCS) might be of help in this context. tDCS is a new NIBS technique with a good safety profile, easy implementation, good patients' tolerance and little or no adverse effects. tDCS uses low levels of constant current delivered to specific brain area via sponge electrodes placed on the scalp. tDCS modifies the polarization of the exposed neuronal circuits. Indeed, it modulates the spontaneous neuronal excitability and activity by a tonic depolarization or hyperpolarization of resting membrane potential.
Therefore, applying a home-based intervention is of interest in a population suffering from high levels of physical disability prohibiting them from frequently coming to seek care at the hospital
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite MS diagnosis according to the 2017 McDonald criteria
- •Fatigue since more than 6 months as assessed by fatigue severity scale (FSS>5)
- •Age between 18 and 75 years.
- •Stable pharmacological and physical treatment since at least one month
- •Affiliation to the social security regimen
- •Signature of the informed consent
- •Ability of the patient to understand the instructions for use of the pacemaker to ensure safe use
排除标准
- •Relapses within the last two months
- •Active medical device implanted
- •Intracranial metal implants
- •Craniotomy, cranial trepanation, aneurysm
- •Uncontrolled epilepsy
- •Non-weaned alcoholism, sleep debt
- •Expanded disability status scale ≥ 6.5
- •Severe depression based on Beck Depression inventory (BDI>19)
- •Daytime sleepiness based on Epworth Sleepiness Scale (ESS> 11)
- •Other neurologic and psychiatric diseases
- •Known pregnancy by the investigator or breastfeeding
- •Physical or mental incapacity to give informed consent
- •Participation in another study (exclusion period following a previous study should be ≥ 6 months)
- •Patients on AME
- •Patients under legal protection
- •Prisoners
结局指标
主要结局
Tiredness
时间窗: 12 weeks
Modified Fatigue Impact Scale (MFIS): cognitive (10 items), physical (9 items) and psychosocial fatigue (2 items). It is a shortened version of the Fatigue Impact Scale that contains 21 of the original 40 items.
次要结局
- Anxiety(12 weeks)
- Depression(12 weeks)
- Alexithymia(before and after each stimulation period (active and simulated) and four weeks later (four weeks after the last stimulation session of each period).)
- Cognitive functions(12 weeks)
- MSQOL scale(12 weeks)