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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03366233
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Romain Meeusen, Vrije Universiteit Brussel

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mental Fatigue Healthy Other: Mental fatigue Other: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Arm Intervention/treatment
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
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.
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Blood Oxygen Level Dependent - Signal during a 10-min cognitive task (i.e. Flanker task) [ 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. ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366233


Locations
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Belgium
Human Physiology and Sports Physiotherapy Research Group
Brussels, (non-US), Belgium, 1050
Sponsors and Collaborators
Vrije Universiteit Brussel
More Information
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Responsible Party: Romain Meeusen, Principal Investigator, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT03366233    
Other Study ID Numbers: MF-MRI
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue
Mental Fatigue
Behavioral Symptoms