The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2018
CompletedOctober 8, 2019
October 1, 2019
9 months
December 1, 2017
October 4, 2019
Conditions
Outcome Measures
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)
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.
Study Arms (2)
Mentally fatiguing task
EXPERIMENTALA modified Stroop task of 90 min, partitioned in 8 blocks of 252 stimuli, will be used as mentally fatiguing task.
Control task
PLACEBO COMPARATORIn 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Healthy (No neurological/cardiorespiratory/psychological disorders)
- No medication
- Non-smoker
- Between 18 and 35 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Human Physiology and Sports Physiotherapy Research Group
Brussels, (non-US), 1050, Belgium
Related Publications (1)
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.
PMID: 35964356DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 1, 2017
First Posted
December 8, 2017
Study Start
February 1, 2018
Primary Completion
November 9, 2018
Study Completion
November 9, 2018
Last Updated
October 8, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share