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Completed

NCT Number: NCT03366233

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

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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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Physiology and Sports Physiotherapy Research Group

Brussels, (non-US), 1050, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mental fatigue

Other

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.

Control

Other

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.

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2017
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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