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临床试验/NCT04577677
NCT04577677招募中不适用

Understanding the Neural Mechanisms Behind Transcranial Direct Current Stimulation

KU Leuven2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
KU Leuven
入组人数
130
试验地点
2
主要终点
Visual Analogue Scale

研究概览

简要总结

The aim of the study is to investigate the neural mechanisms underpinning transcranial direct current stimulation (tDCS), a non-invasive neuromodulation technique in which a direct current is passed through scalp electrodes. A series of experiments will be conducted to understand and characterize the transcranial and transcutaneous mechanisms of tDCS. To investigate this research question, every participant will undergo three stimulation conditions (active, sham and control). In the control condition, an anaesthetic cream will be applied to anaesthetize the nerves in the scalp. In addition, the effectiveness of tDCS and peripheral nerve stimulation will be compared. Ultimately, the obtained knowledge can lead to the development of improved non-invasive neuromodulation therapies, which can lead to more effective treatments of a variety of neurological and psychiatric disorders.

研究设计

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

入排标准

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

入选标准

  • good general health

排除标准

  • Epilepsy or family history of epilepsy
  • Allergic to lidocaine or benzocaine
  • History of or currently suffering from:
  • neurological diseases
  • psychiatric diseases, depression or anxiety (Annex B and Annex C)
  • History of:
  • brain surgery
  • brain thrombosis
  • cerebral hemorrhage
  • severe head trauma
  • meningitis
  • long period of loss of consciousness (> 1 hour)
  • Metal parts in the head or upper body:
  • Defibrillator, implanted medication pump
  • Metal prosthesis in ear, hart, ...
  • Deep brain stimulator
  • Coronary bypass or intracranial or aneurysm clips (brain arteries, aorta, etc.)

结局指标

主要结局

Visual Analogue Scale

时间窗: 30 minutes during stimulation

Rate sensation from 0 ('I feel nothing') to 10 ('Stimulation is painful')

Reaction time

时间窗: 20 minutes during peripheral nerve stimulation

Reaction time on motor learning task

Amplitudes of event related potentials

时间窗: during peripheral nerve stimulation

ERP during stimulation

Pupil dilations

时间窗: during peripheral nerve stimulation

pupil diameter during stimulation

次要结局

未报告次要终点

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Myles Mc Laughlin

Professor

KU Leuven

研究点 (2)

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