Healthy Subjects Clinical Trial
Verified date | January 2014 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | September 7, 2015 |
Est. primary completion date | September 7, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - healthy male and non-pregnant, non-breastfeeding female participants, aged 18-60 years old at the time of consent. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven, campus Gasthuisberg | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | Katholieke Universiteit Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cognitive inhibitory performance on Stroop task (reaction time, in milliseconds) and intertemporal choice task (discount parameter, no unit) | response reaction time on Stroop task discount parameter on intertemporal choice task |
30 minutes |
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