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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: induction of urge by rectal distension

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven, Campus Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2014
• Primary Completion (Actual): September 7, 2015
• Study Completion (Actual): September 7, 2015

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: S56275