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CompletedNCT03366233Updated Oct 8, 2019

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

An interventional study of Mental fatigue and Control in Mental Fatigue and Healthy, sponsored by Vrije Universiteit Brussel. Completed at 1 site in Belgium. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-08.

Sponsored by Vrije Universiteit Brussel · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

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Conditions studied

  • Mental Fatigue
  • Healthy

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03

In context

Mental Fatigue

159 studies on the registry are indexed under Mental Fatigue; 55 are open to participants now.

This study's enrollment of 20 is below the median of 45 across 129 interventional studies indexed under Mental Fatigue.

Browse Mental Fatigue studies →

Lead sponsor

Vrije Universiteit Brussel is the lead sponsor of 157 studies on the registry; 44 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Mentally fatiguing task

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

    Other: Mental fatigue

  • Placebo comparator
    Control 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.

    Other: Control

Interventions

  • OtherMental fatigue

    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.

  • OtherControl

    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.

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What researchers measure

Primary outcomes

  1. 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)

    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.

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Study locations

1 site
  • Human Physiology and Sports Physiotherapy Research Group
    Brussels, (non-US) 1050, Belgium
08

References and documents

Publications

  • 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. PubMed 35964356 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Nov 2018, 9 months.

Of 74 non-industry interventional studies with no phase under Mental Fatigue, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 23. This study's 9 months is close to that.

Counting every sponsor, half of 87 studies reached it within 7 months; a quarter within 3 and three quarters within 22.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2017
First posted
Dec 8, 2017
StartActual
Feb 1, 2018
Primary completionActual
Nov 9, 2018
CompletionActual
Nov 9, 2018
Last update
Oct 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03366233
Responsible party
Romain Meeusen (Principal Investigator, Vrije Universiteit Brussel) — Principal investigator
First posted
Dec 8, 2017
Start date
Feb 1, 2018
Primary completion
Nov 9, 2018
Completion
Nov 9, 2018
Last update
Oct 8, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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