NCT03658668已完成不适用
Study of the Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in Gait Velocity
研究概览
简要总结
This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when administered simultaneously with PA on walking, functional mobility, and fatigue.
The subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the sham group (sham tDCS+PA).
Portions of this study may be completed remotely.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable and continuous access to internet service at home
- •Adequate home facilities (enough space, access to quiet and distraction free area)
- •Definite MS diagnosis, subtype relapsing-remitting (RR-MS)
- •Disability Status Scale (EDSS) from 1 to 6.5 with clinically significant gait deviations
- •Clinically stable and stable on treatment with disease modifying agents at least from 6 months
- •Able to independently walk with or without an assisting device (i.e. cane, crutches or walking frames) for medium-long distance
- •Absence of other associated medical conditions that would prevent participants from performing physical activity, such as cardiorespiratory and severe osteoarticular disorders
- •Able to use study equipment
- •Able to commit 10 consecutive daily sessions of tDCS while performing physical program with baseline and follow-up visits
- •Able to understand the informed consent process and provide consent to participate in the study
排除标准
- •Visual, auditory and motor deficits that would prevent full ability to understand study, as judged by treating neurologist or study staff
- •Primary psychiatric disorder that would influence ability to participate
- •Receiving current treatment for epilepsy
- •Uncontrolled headaches and migraines. In addition, if a subject has had a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they are excluded
- •History of head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
- •Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
- •Treatment for a communicable skin disorder currently or over the past 12 months
- •History of uncontrolled or labile hypertension
- •Other serious uncontrolled medical condition (e.g. cancer or acute myocardial infarction)
- •Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score < 85
- •History of clinically significant abnormalities on electrocardiogram (EKG)
- •Presence of chronic medical illness and/or severe ataxia
- •Botulinum toxin injection within the past 4 months or functional surgery in the past 6 months
- •Alcohol or other substance use disorder
- •Pregnant or breastfeeding
结局指标
主要结局
Change in Gait Velocity
时间窗: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Measured by a 10 meter walk test using wearable inertial sensors
Change in Stride Length
时间窗: Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Measured by a 10 meter walk test using wearable inertial sensors
次要结局
- Change 21-item Modified Fatigue Impact Scale Score(Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks))
- Percent of tDCS Sessions Completed(End of Final Treatment Session (Up to Week 3))
- Change in 12-item Multiple Sclerosis Walking Scale Score(Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks))
研究者
研究点 (1)
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