Pilot Study of Transcranial Direct Current Stimulation (tDCS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- The Number of Participants Completing at Least 80% of the Targeted Sessions.
研究概览
简要总结
This study will test the tolerability and preliminary efficacy of transcranial direct current stimulation (tDCS) combined with a cognitive training program, remotely-delivered using a telemedicine protocol in 60 adults with multiple sclerosis (MS). The study will evaluate the efficacy of tDCS to evaluate two of the most debilitating symptoms of MS: cognitive impairment and fatigue.
详细描述
Transcranial direct current stimulation (tDCS) has been demonstrated to:
- successfully treat fatigue in adults with MS, and
- improve learning ability and other aspects of cognitive functioning in healthy controls and in participants with a range of medical disorders.
Cognitive impairment in MS remains a major treatment challenge and a trial of tDCS combined with a cognitive training program to treat MS-related cognitive impairment is warranted. However, one barrier for the study of tDCS has been the need for the participant to travel to the study site for each tDCS administration. To address this issue, the biomedical company Soterix, has recently designed a remote-delivery tDCS device designed for use in clinical trials. Therefore, the primary goal of this study is to establish a protocol for remotely-supervised in-home tDCS delivery for studies with MS participants. Established safety and feasibility of remotely-supervised tDCS delivery will facilitate the next steps of larger controlled trials, in both MS as well as other conditions, to determine efficacy and appropriate real-world use.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-70
- •Definite MS diagnosis, all subtypes [95]
- •MS-related changes in cognitive functioning
- •A score of 6.5 or lesson the Expanded
- •Disability Status Scale (EDSS) OR more than 6.5 with proxy
- •Has stable and continuous access to internet service at home compatible with the study laptop (Wi-Fi or ethernet cable)
- •Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/)
- •Adequate home facilities (enough space, access to quiet and distraction free area)
- •Able to commit to the two-week period of training sessions 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 instructions or operate the tDCS device or study laptop, as judged by treating neurologist or study staff
- •Relapse or steroid use in previous month
- •History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
- •Primary psychiatric disorder that would influence ability to participate
- •History of seizures or seizure disorder
- •Current chronic headaches or 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
结局指标
主要结局
The Number of Participants Completing at Least 80% of the Targeted Sessions.
时间窗: Four Weeks
80% is equivalent to n=16 of the targeted 20 transcranial direct current stimulation (tDCS) or sham tDCS sessions.
Change in Total Score of the Brief International Assessment of Cognition in MS (BICAMS)
时间窗: Baseline, Four Weeks
BICAMS comprises two tests, the Symbol Digit Modalities Test (SDMT) and the Brief Visuospatial Memory Test-Revised (BVMT-R). Scoring for SDMT involves summing the number of correct substitutions within the 90 second interval (max = 110. The higher the score, the better). Visual/spatial memory is assessed in BICAMS using the BVMTR. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12 (the higher the score, the better). The total score range for BICAMS is 0-122. The higher the score, the better.
次要结局
- Change in Score of CogState Brief Battery (CBB)(Baseline, 4 Week)
- Change in Score on Modified Fatigue Impact Scale (MFIS)(Baseline, 4 Weeks)