跳至主要内容
临床试验/NCT02043561
NCT02043561已完成不适用

The Effect of Inhibitory Control Processes Induced by Rectal Distension on Impulse Control Measured by Stroop Task Performance and Intertemporal Discounting.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2014年12月24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
入组人数
35
试验地点
1
主要终点
cognitive inhibitory performance on Stroop task (reaction time, in milliseconds) and intertemporal choice task (discount parameter, no unit)

研究概览

简要总结

The aim of this study will be to investigate the effect of rectal distension, controlled by electronic barostat, on cognitive control ability in healthy subjects. We will use the Stroop task and an intertemporal choice task as standard instruments. Like bladder control and rectal control, both Stroop task performance and intertemporal choices - though very different tasks at the surface - are dependent on the conflict monitoring function of the anterior cingulate cortex. The Stroop task requires the naming of the print color of a series of visually presented color words, and reaction time and error rates are typically used as performance indicators. When word color and word meaning do not match, performance of the task (color naming) requires the inhibition of a (near) automatic response (word reading). The intertemporal choice task consists of a series of choices between a sooner smaller monetary reward and a larger but later reward. The choices are constructed such that they allow the estimation of a discount parameter, which is an index for the level of impulsiveness manifested by the participant at the time the choices are made.

The hypothesis is that the inhibition induced by the urge generated during rectal distension will improve cognitive inhibitory performance, as has previously been shown for bladder filling.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •healthy male and non-pregnant, non-breastfeeding female participants, aged 18-60 years old at the time of consent.

排除标准

  • •use of medications within 48 h of dose initiation; structural or metabolic diseases that affect the gastrointestinal system and functional gastrointestinal disorders; previous abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, or hernia repair; known illnesses such as diabetes, cardiovascular or lung disease; current psychiatric disorders (anxiety, depression, substance use); use of agents that influence bowel habit, i.e. anticholinergics (not including antihistamines with anticholinergic properties), spasmolytics and prokinetics in the 7 days before the study.

研究组 & 干预措施

no urge

Sham Comparator

rectal balloon deflated

干预措施: induction of urge by rectal distension (Other)

moderate urge

Experimental

moderate urge induced by rectal balloon

干预措施: induction of urge by rectal distension (Other)

high urge

Experimental

high urge induced by rectal balloon

干预措施: induction of urge by rectal distension (Other)

结局指标

主要结局

cognitive inhibitory performance on Stroop task (reaction time, in milliseconds) and intertemporal choice task (discount parameter, no unit)

时间窗: 30 minutes

* response reaction time on Stroop task * discount parameter on intertemporal choice task

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验