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临床试验/NCT03886025
NCT03886025招募中不适用

The Use of Combined Anodal Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Modulate Decision-making in Healthy People

Dr. Najat Khalifa2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月15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
入组人数
60
试验地点
2
主要终点
Iowa Gambling Task (IGT) net scores

研究概览

简要总结

This study aims to (i) assess the effects of combined tDCS and cognitive training on decision-making on a trained task (Iowa Gambling Task; IGT); and (ii) test generalization to a closely related cognitive domain, namely motor impulsivity. It is hypothesized that combined anodal tDCS and cognitive training will result in more advantageous decisions and better impulse control than combined sham tDCS and cognitive training.

详细描述

Impaired decision-making under conditions of uncertainty and risk has been implicated in maladaptive personality development and violent behaviour. There is a dearth of studies that examined the effects of combined tDCS and cognitive training on decision-making under conditions of uncertainty and risk. It is also unclear if these effects are generalizable to tasks in other domains such as response inhibition (motor impulsivity).

To examine these issues further, a single blind parallel arms randomized controlled trial will be conducted, involving a sample of healthy volunteers aged between 18 and 40. This will entail applying either active or sham tDCS over the anterior frontal cortex (including the vm-PFC) while participants undertake decision-making training using the Iowa Gambling Task. Decision-making will be assessed using the IGT, which is a computerized gambling task used to assess decision-making under conditions of uncertainty and risk. IGT is sensitive to damage to the ventromedial prefrontal cortex (vmPFC), which is considered to play a key role in decision-making. Motor impulsivity will be measured using the Stop Signal Task (SST). The UPPS+P Impulsive Behaviour Scale will be used to index trait impulsivity. The Profile of Mood States will be used to measure state emotion before and after tDCS.

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
Single (Participant)

盲法说明

Participants will be randomly assigned to receive either combined anodal tDCS and cognitive training or combined sham tDCS and cognitive training. The participants will be blind to whether the tDCS is active or sham.

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

  • Consenting volunteers aged between 18 and 40.

排除标准

  • Individuals with epilepsy, other neurological conditions and history of significant head injury will be excluded.
  • Individuals with a history of substance misuse, major mental disorder and those receiving psychotropic medication will be also excluded.

结局指标

主要结局

Iowa Gambling Task (IGT) net scores

时间窗: Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation

IGT is a measure of decision making under conditions of uncertainty and risk.

次要结局

  • Stop Signal Task (SST) reaction time(Change from baseline after 20 minutes of combined cognitive training and tDCS stimulation)
  • Abbreviated Profile of Mood States (POMS) Total Mood Disturbance score(Baseline)
  • Urgency, Perseveration, Premeditation, Sensation Seeking + Positive Urgency (UPPS+P) Impulsive Behavior Scale total scores(Baseline)

研究者

发起方
Dr. Najat Khalifa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Najat Khalifa

Associate Professor

Queen's University

研究点 (2)

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