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临床试验/NCT02402101
NCT02402101已完成3 期

Effect of the Transcranial Direct Current Stimulation on the Dopaminergic

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Change in dopamine transmission after 1 session of 20min tDCS

研究概览

简要总结

Transcranial direct current stimulation (tDCS) is a technique that is emerging as a prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with improvement of cognitive functions and mood. Despite an increased use in clinical settings, tDCS suffers from limitations, especially regarding the strength and the duration of therapeutic effects. Strategies to optimize the conditions for tDCS application suffer from the lack of knowledge about its neurophysiological impact. Moreover, tDCS is increasingly used in private settings through commercial apparatus and tutorials to make a "do-it-yourself" device delivering tDCS now available on the Internet. This private use worries neuroscientists and health authorities. Even if the general impression is that, in controlled conditions, tDCS is safe with only mild and transient adverse effects, whether and how tDCS could be used for enhancing cognition in healthy subjects are needed to investigate in more detail. The investigators believe that a better understanding of some neurobiological effects of tDCS is crucial to further tailor tDCS for experimental and therapeutic applications and to define recommendations for a private use.

As the cortex is densely connected with basal ganglia areas, including dopaminergic areas, tDCS is probably not only capable to target cortical but also subcortical structures remote from the stimulation sites. Some studies suggest that cortical stimulation by other approaches, such as transcranial magnetic stimulation (rTMS) leads to an increased dopaminergic transmission. The involvement of dopaminergic systems in tDCS effects has been investigated only indirectly in pharmacological studies. Thus, the direct effect of the DLPFC stimulation by tDCS on dopaminergic transmission is still unknown.

The aim of this project is to reveal the online impact of a single-session of tDCS applied bilaterally over the DLPFC in healthy subjects on the dopaminergic transmission measured by PET, combined with the [11C]raclopride bolus-plus-continuous-infusion method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Non smoker
  • No pyschotrope consumption
  • No medical treatment
  • No psychiatric or somatic (neurological, endocrine, cardiac, renal)
  • Affiliated to the french social security

排除标准

  • No consent
  • For females : Pregnant or without birth control
  • Contraindications to stimulation by tDCS or to an MRI exam
  • Being in an exclusion period or over the annual compensation ceiling
  • Participation in another study using ionizing radiation in less than a year

结局指标

主要结局

Change in dopamine transmission after 1 session of 20min tDCS

时间窗: during 100min of PET scan : Baseline (20-40min), during stimulation (40-60min) and after stimulation (60-80min & 80-100min)

Measure of the Binding Ratio defined as the ratio of : region of interest / cerebellum activities)

次要结局

未报告次要终点

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Sponsor

研究点 (2)

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