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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366233
• Other study ID #: MF-MRI
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: November 9, 2018

Study information

• Verified date: October 2019
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Healthy
• Mental Fatigue

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Human Physiology and Sports Physiotherapy Research Group	Brussels	(non-US)

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.