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临床试验/NCT03036683
NCT03036683已完成不适用

The Effect of Transcranial Direct Current Stimulation on Risk-taking and Aggression in Offenders

Olivia Choy1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
Number of balloon pumps in the Balloon Analogue Risk Task after stimulation

研究概览

简要总结

This study investigates the effect of upregulating prefrontal cortex activity on risk-taking, and antisocial and aggressive behavior in violent offenders. In the double-blind, randomized controlled trial, using a within-subject crossover design, each participant will undergo anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex and sham stimulation. After each stimulation session, neural activity and behavioral responses to tasks assessing risk-taking and aggressive behavior will be recorded. The effect of tDCS on violent offenders will also be assessed in comparison to age and gender-matched healthy controls.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Between 18 and 50 years of age
  • •Able to understand the nature of the study and give informed consent
  • •Individuals in the violent offender group must have a record of repeated violent criminal offending (at least 2 felonies).
  • •Individuals in the violent offender group must have been convicted solely due to crimes involving violence motivated by impulsive aggression.

排除标准

  • •Presence of any contraindications for functional magnetic resonance imaging (fMRI)
  • •History of significant medical illness
  • •History of any neurological condition
  • •Diagnosis of schizophrenia
  • •History of epilepsy
  • •Head injury
  • •Mental retardation

研究组 & 干预措施

Anodal stimulation

Experimental

Participants in the active stimulation group will undergo anodal transcranial direct current stimulation (tDCS). tDCS will be delivered by a battery-driven, constant-current stimulator connected to two saline-soaked surface sponge electrodes. An anodal electrode (25cm2) will be placed over the right dorsolateral prefrontal cortex and one cathodal electrode (100cm2) will be placed over the left supraorbital area at least 5cm from the anode. Scalp electrodes will be positioned according to the 10-20 EEG international system. A current of 2mA will be applied for 20 minutes and the current will be ramped up and down over 20 seconds at the beginning and end of the stimulation period.

干预措施: Transcranial direct current stimulation (Device)

Sham stimulation

Sham Comparator

The sham tDCS condition will involve the same placement of the electrodes, current intensity, and ramp-up/down time as the active tDCS condition, but stimulation will only last for 30 seconds.

干预措施: Sham transcranial direct current stimulation (Device)

结局指标

主要结局

Number of balloon pumps in the Balloon Analogue Risk Task after stimulation

时间窗: Within 1 hour after the 20-minute tDCS or sham session ends

The number of balloon pumps, measured by the number of times subjects press a button to pump up a computerized balloon over 60 trials, will be assessed.

Neural activity during Balloon Analogue Risk Task after stimulation

时间窗: Within 1 hour after the 20-minute tDCS or sham session ends

Functional brain activity and connectivity will be assessed using functional magnetic resonance imaging.

Antisocial behavior inclinations after stimulation

时间窗: Within 1 hour after the 20-minute tDCS or sham session ends

This will be assessed using 8 hypothetical scenarios in which someone commits a criminal or antisocial act. Participants will respond to the likelihood that they would commit the act in the scenario according to a 10-point Likert scale.

Aggressive behavior after stimulation

时间窗: Within 1 hour after the 20-minute tDCS or sham session ends

This will be assessed according to performance on the violent video game, Carmageddon: TDR 2000 (Klasen et al., 2013; Torus Games, Bayswater, Australia, 2000) in comparison to a modified non-violent version of the game.

Neural activity during aggression task after stimulation

时间窗: Within 1 hour after the 20-minute tDCS or sham session ends

Functional brain activity and connectivity during participation in the video game will be assessed using functional magnetic resonance imaging.

次要结局

  • Number of participants with adverse events(Within 1 hour after the 20-minute tDCS or sham session ends)
  • Ratings of moral wrongfulness regarding antisocial acts after stimulation(Within 1 hour after the 20-minute tDCS or sham session ends)
  • Ratings of guilt or shame regarding antisocial acts after stimulation(Within 1 hour after the 20-minute tDCS or sham session ends)

研究者

发起方
Olivia Choy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Olivia Choy

PhD candidate

University of Pennsylvania

研究点 (1)

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