Mental FatigueNCT03366233
The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.
A study testing Mental fatigue in people with Mental Fatigue and Healthy, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue, Healthy
- What is being tested?
- Mental fatigue
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2018to 9 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (No neurological/cardiorespiratory/psychological disorders)
- No medication
- Non-smoker
- Between 18 and 35 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Human Physiology and Sports Physiotherapy Research Group
Brussels, (non-US), 1050
About this study
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.
- Conditions
- Mental Fatigue, Healthy
- Being tested
- Mental fatigue, Control
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental fatigueOther
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mentally fatiguing task | Experimental | A modified Stroop task of 90 min, partitioned in 8 blocks of 252 stimuli, will be used as mentally fatiguing task. Receives: Other: Mental fatigue |
| Control task | Placebo comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Feb 2018
- Primary completion9 Nov 2018
- Study completion9 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental FatigueStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Meeusen, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366233
- Sponsor's protocol ID
- MF-MRI
- Status last verified
- Oct 2019
- First submitted
- 1 Dec 2017
- Last updated
- 8 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.
- ClinicalTrials.gov ID
- NCT03366233
- Acronym / sponsor ID
- MF-MRI
- Conditions
- Mental Fatigue, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 8 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mentally fatiguing task | Experimental | Other: Mental fatigueA modified Stroop task of 90 min, partitioned in 8 blocks of 252 stimuli, will be used as mentally fatiguing task. |
| Control task | Placebo comparator | Other: ControlIn 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy (No neurological/cardiorespiratory/psychological disorders)
- No medication
- Non-smoker
- Between 18 and 35 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental fatigueA 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. | Other | Mentally fatiguing task |
| ControlIn 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. | Other | Control task |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Derived from this study: PubMed 35964356Van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental fatigue in people with Mental Fatigue and Healthy, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03366233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.