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临床试验/NCT01135953
NCT01135953已完成不适用

Investigating Methods to Enhance the Excitatory Effects of Transcranial Direct Stimulation (tDCS)

The University of New South Wales2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change from baseline in brain excitability measured through motor evoked potentials (MEP) 0 to 120 minutes after tDCS session.

研究概览

简要总结

tDCS has been shown to be an effective treatment for depression. However, tDCS is a relatively new clinical tool and more needs to be understood about its use. This study hopes to further the field of knowledge by examining how tDCS should be optimally used. Application of tDCS in clinical trials of depression is typically to the prefrontal cortex, but in this project, tDCS application will be to the motor cortex as it provides a more ready measure of excitability. Excitability will be measured using Transcranial Magnetic Stimulation (TMS) to the motor cortex and electromyography (EMG) recordings from peripheral muscles stimulated. Using a cross-over three-arm design this study aims to investigate whether daily tDCS administered in increasing intensity across sessions leads to greater and lasting effects on brain excitability than keeping the intensity at a same dose across the days and whether the excitatory effect could be enhanced with D-cycloserine, a medication known to prolong the excitatory effects of a single session of tDCS. This in turn will inform on how to optimize tDCS for therapeutic applications, e.g treatment of depression. The study hypothesis is that 5 sessions of tDCS with a dose of D-cycloserine given on the Monday and Thursday sessions will result in more sustained effect on motor cortex excitability than 5 sessions of tDCS alone. The second hypothesis is that the gradational increases in tDCS intensity over 5 sessions will result in greater motor cortex excitability than 5 sessions of tDCS where intensity is kept constant across sessions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Right handed (> 18/20 on the Edinburgh Handedness)
  • Aged 18-40

排除标准

  • Mental illness
  • General medical illness
  • Neurological illness, epilepsy
  • Alcohol use above National Health and Medical Research Council (NHMRC) guidelines
  • Excessive caffeine intake
  • Illicit drug use
  • Herbal medication use
  • Electronic implant, e.g, cochlear implant, pacemaker
  • Musculoskeletal problem in the arm

结局指标

主要结局

Change from baseline in brain excitability measured through motor evoked potentials (MEP) 0 to 120 minutes after tDCS session.

时间窗: Pre-treatment, post treatment at minute 0, minute 5, minute 10, minute 15, minute 20, minute 25, minute 30, minute 60, minute 90, minute 120.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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