Pilot Study of Transcranial Direct Current Stimulation (tDCS)
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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New York、New York、美国、10016
- New York University Langone Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Transcranial Direct Current Stimulation (tDCS)
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tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability.
tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
其他名称:
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假比较器:Sham Transcranial Direct Current Stimulation (tDCS)
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During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session.
These brief periods of stimulation serve to mimic the effects of a true stimulation session.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Number of Participants Completing at Least 80% of the Targeted Sessions.
大体时间:Four Weeks
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80% is equivalent to n=16 of the targeted 20 transcranial direct current stimulation (tDCS) or sham tDCS sessions.
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Four Weeks
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Change in Total Score of the Brief International Assessment of Cognition in MS (BICAMS)
大体时间:Baseline, Four Weeks
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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. |
Baseline, Four Weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Score on Modified Fatigue Impact Scale (MFIS)
大体时间:Baseline, 4 Weeks
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MFIS consists of 21 statements.
The number that best indicates how often fatigue has affected the participant in the manner described during the past 4 weeks is circled.
Answer choices include: 0 - never, 1 - rarely, 2 - sometimes, 3 - often, 4 - almost always.
The total score ranges from 0 to 84.
The higher the number, the more frequently fatigue impacted the participant during the past 4 weeks.
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Baseline, 4 Weeks
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Change in Score of CogState Brief Battery (CBB)
大体时间:Baseline, 4 Week
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CBB is a brief, computer-administered cognitive test battery that requires approximately 10 minutes for administration.
If the CBB score falls between -10 to +10, it is considered normal.
CogState scoring is such that 0 could be considered as performing in the average range for that subtest compared to people of similar age.
A negative score means that the performance was lower than average, and a positive score means the performance was higher than average.
Higher positive scores (for instance 0.2 becoming 0.5) may indicate slightly better performance and higher negative scores (for instance, -0.4 becoming -0.8) may indicate slightly worsening performance.
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Baseline, 4 Week
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合作者和调查者
调查人员
- 首席研究员:Leigh Charvet、NYU Langone Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 15-01189
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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