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The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.

Primary Purpose

Mental Fatigue, Healthy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mental fatigue
Control
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mental Fatigue

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy (No neurological/cardiorespiratory/psychological disorders)
  • No medication
  • Non-smoker
  • Between 18 and 35 years old

Exclusion Criteria:

  • Injuries
  • Illness
  • Pacemaker, neurostimulator, medication pump or metal implants
  • Use of medication or any kind of drugs
  • Use of alcohol, caffeine and heavy efforts 24 hours before each trial
  • Not eating the same meal the night before and the morning of each trial

Sites / Locations

  • Human Physiology and Sports Physiotherapy Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mentally fatiguing task

Control task

Arm Description

A modified Stroop task of 90 min, partitioned in 8 blocks of 252 stimuli, will be used as mentally fatiguing task.

In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial for 90 min.

Outcomes

Primary Outcome Measures

Blood Oxygen Level Dependent - Signal during a 10-min cognitive task (i.e. Flanker task)
Blood Oxygen Level Dependent - Signal will be measured during a 10-min Flanker task that will be completed immediately before and after the 90-min task (i.e. documentary in control trial; stroop task in intervention trial)

Secondary Outcome Measures

Full Information

First Posted
December 1, 2017
Last Updated
October 4, 2019
Sponsor
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03366233
Brief Title
The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.
Official Title
The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
November 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To assess the changes in brain activation and cerebral blood flow due to mental fatigue in a placebo-controlled study. More specifically we want to assess whether brain activation [measured with Blood Oxygen Level Dependent (BOLD) functional resonance imaging (fMRI)] is decreased during a Flanker task in a mentally fatigued state and whether this coincides with a decline in cognitive performance. In addition we also want to evaluate whether cerebral blood flow [measured with arterial spin labeled (ASL) fMRI] in a resting state is reduced when mentally fatigued.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Fatigue, Healthy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mentally fatiguing task
Arm Type
Experimental
Arm Description
A modified Stroop task of 90 min, partitioned in 8 blocks of 252 stimuli, will be used as mentally fatiguing task.
Arm Title
Control task
Arm Type
Placebo Comparator
Arm Description
In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial for 90 min.
Intervention Type
Other
Intervention Name(s)
Mental fatigue
Intervention Description
A modified Stroop task of 90 min, partitioned in 8 blocks of 252 stimuli, will be used as mentally fatiguing task. The Stroop task requires inhibition and sustained attention on controlled processes.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial. These documentaries are chosen based on their emotionally neutral, yet engaging content.
Primary Outcome Measure Information:
Title
Blood Oxygen Level Dependent - Signal during a 10-min cognitive task (i.e. Flanker task)
Description
Blood Oxygen Level Dependent - Signal will be measured during a 10-min Flanker task that will be completed immediately before and after the 90-min task (i.e. documentary in control trial; stroop task in intervention trial)
Time Frame
Blood Oxygen Level Dependent - Signal will be measured during a 10-min Flanker task that will be completed immediately prior and after the 90-min task that is completed in both trials.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy (No neurological/cardiorespiratory/psychological disorders) No medication Non-smoker Between 18 and 35 years old Exclusion Criteria: Injuries Illness Pacemaker, neurostimulator, medication pump or metal implants Use of medication or any kind of drugs Use of alcohol, caffeine and heavy efforts 24 hours before each trial Not eating the same meal the night before and the morning of each trial
Facility Information:
Facility Name
Human Physiology and Sports Physiotherapy Research Group
City
Brussels
State/Province
(non-US)
ZIP/Postal Code
1050
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35964356
Citation
Van Cutsem J, Van Schuerbeek P, Pattyn N, Raeymaekers H, De Mey J, Meeusen R, Roelands B. A drop in cognitive performance, whodunit? Subjective mental fatigue, brain deactivation or increased parasympathetic activity? It's complicated! Cortex. 2022 Oct;155:30-45. doi: 10.1016/j.cortex.2022.06.006. Epub 2022 Jun 30.
Results Reference
derived

Learn more about this trial

The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.

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