NCT03366233

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2018

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

December 1, 2017

Last Update Submit

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

EXPERIMENTAL

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

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.

Other: Control

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.

Mentally fatiguing task
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.

Control task

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

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

Locations