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CompletedNCT02043561Updated Sep 11, 2017

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

An interventional study of induction of urge by rectal distension in Healthy Subjects, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-11.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
35 participants (actual)

Study arms

  • Sham comparator
    no urge

    rectal balloon deflated

    Other: induction of urge by rectal distension

  • Experimental
    moderate urge

    moderate urge induced by rectal balloon

    Other: induction of urge by rectal distension

  • Experimental
    high urge

    high urge induced by rectal balloon

    Other: induction of urge by rectal distension

Interventions

  • Otherinduction of urge by rectal distension
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 minutes

07

Study locations

1 site
  • University Hospitals Leuven, campus Gasthuisberg
    Leuven, 3000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02043561
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
Responsible party
Sponsor
First posted
Jan 23, 2014
Start date
Dec 24, 2014
Primary completion
Sep 7, 2015
Completion
Sep 7, 2015
Last update
Sep 11, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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