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临床试验/NCT02717260
NCT02717260已完成不适用

Inhibition Control Modulation by Transcranial Random Noise Stimulation (tRNS ) on the Prefrontal Cortex Measured by Change in Go no Test

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Change in go no go test

研究概览

简要总结

Inhibition control deficits is a major risk factor in the transition to the act in suicidal patients. Neuroimaging studies have shown that this failure was associated with hypoactivity in the prefrontal cortex (PFC), a brain area involved in the control of impulsivity. It was recently shown that a noninvasive brain stimulation session applied on the PFC reduces transiently impulsivity in healthy volunteers. Noninvasive brain stimulation modulates the activity and connectivity of neural network connected to the stimulation site. The investigators assume that a repetition of noninvasive brain stimulation sessions on the PFC will allow a more intense and longer lasting effect on impulsivity and cognitive control in healthy volunteers compared to a single session and to placebo stimulation. The investigators assume that this behavioral change will be accompanied by a change in brain activity measured by resting EEG for the patients in the active group. A more intense and longer lasting effect is an essential step to transfer these results to patient populations.

The main objective is to study the effect of bilateral stimulation of the PFC by transcranial random noise stimulation (tRNS) on the inhibition control measured by the cognitive motor inhibition capacity (Go NoGo test). The secondary objectives are to study the effect of tRNS on verbal inhibition (measured with the Hayling test); on anxiety (measured with the State-trait anxiety inventory (STAI)),on angry (measured with the State-trait anger expression inventory (STAXI)) on verbal and nonverbal inhibition (measured by the Stroop test), on impulsive behavior (measured by the Barrat impulsiveness scale (BIS 10)) and on the neuronal electrical activity measured by EEG.

详细描述

Subjects are stimulated 3 times in a day. Each 20 minutes stimulation are separated by a period of at least 30 minutes. Before and after each stimulation, inhibition is evaluated by cognitive tests (Go Nogo test, Stroop test, Hayling test) and by the BIS 10 scale. During the stimulation, subjects compleat the STAXI and STAI scales. Cognitive tests are repeated 24 hours and 8 days after the stimulation to evaluate duration of the effect. Possible side effects will be notified throughout the protocol.

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
Triple (Participant, Care Provider, 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

  • age between 18 and 45 years

排除标准

  • inability to give consent
  • Under 18 years
  • over 45 years
  • pregnant women
  • nursing mothers
  • History of neurological or psychiatric disorders and personality disorders in Cluster impulsivity (cluster B) according to Diagnostic and Statistical Manual (DSM) IV
  • french National Adult Reading Test (fNART): score below the 5th percentile
  • Contraindications to the practice of transcranial brain stimulation as international safety recommendations (Rossi et al., 2009)
  • Processing or recent psychotropic

结局指标

主要结局

Change in go no go test

时间窗: 15 minutes after the stimulation

errors and reaction times

次要结局

  • Change in Stroop test(15 minutes after the stimulation)
  • Change in Hayling test(15 minutes after the stimulation)
  • Change in BIS 10(24 hours and 8 days after stimulations)
  • Change in STAXI(24 hours and 8 days after stimulations)
  • Change in STAI(24 hours and 8 days after stimulations)
  • Change in EEG(24 hours and 8 days after stimulations)
  • occurrence of adverse effects(8 days after stimulations)

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Principal Investigator
主要研究者

HAESEBAERT

MD PhD

Hôpital le Vinatier

研究点 (2)

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