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NCT Number: NCT05880342

The Role of the Brain in Mental and Physical Fatigue

The goal of this clinical trial is to determine the role of brain neurotransmission in the onset of fatigue, identify the brain areas involved, and determine how brain activity and neuromuscular efficiency changes during onset of fatigue. Three different experimental studies (physical fatigue, mental fatigue and combined) will be performed with a randomized, single-blinded, placebo controlled, counter-balanced, cross-over design.

The objectives of the projects are as follows:

* To experimentally assess the role of a dopamine, and a noradrenalin reuptake inhibitor in the onset of exercise-induced fatigue * To identify changes in brain activation associated with altered PF and fatigue perception * To experimentally assess the effect of a NA or DA reuptake inhibitor on MF, brain activation and the sources of changes in brain activation * To experimentally assess the role of brain neurotransmitters (DA, NA) in the interaction between mental and PF from a neurophysiological perspective.

Participants will be healthy young adults. In each study, they will start with a familiarization trial followed by two experimental trials and one control trial with a randomized treatment order. At each visit, different drugs will be administered to elicit different neurotransmitter response. The trials will be performed at the MFYS exercise lab (BLITS, VUB campus Etterbeek, Boulevard General Jaques 271, 1050 Elsene (Brussels)).

Depending on the type of study they are participating in, participants will perform three distinct tasks:

* In the first experimental study participants will perform a 60-min Stroop Task to elicit mental fatigue. * In the second experimental study participants will perform a knee-extension exercise until exhaustion to elicit physical fatigue. * In third experimental study participants will first preform a mental fatiguing task (Stroop taks) followed by physical fatigue task (knee extension).

While participants will perform above mentioned task their EEG signal and heart rate will be measured. At the same time, participants will report on their subjective feeling of fatigue during these tasks. In addition, all participants will be administered cognitive tasks before and after the study, along with questionnaires. In the second and third experiments, tensiomyography and electromyography will also be recorded from the quadriceps muscle of the leg used for knee extension.

Researchers will compare physiological and behavioural changes in response to specific neurotransmitter drug to answer the main question: what the role of a DA and a NA reuptake inhibitor on the onset of mental and physical fatigue is.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brussels Labo voor Inspanning & Topsport U-residence

Brussels, Brussels Capital, 1050, Belgium

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy trained individuals (exercises at least 1x per week, no neurological, cardiovascular internal or musculoskeletal disorders of any kind)
  • No use of chronic or occasional prescribed medication (except for contraceptives)
  • Non-smoker

Exclusion criteria

  • Injuries of any kind in the past 6 months
  • Pregnancy
  • Specific food or drink allergies (e.g. lactose and/or gluten intolerance)
  • Suffering from a chronic health condition (could be neurological, cardiovascular, internal and musculoskeletal)
  • Participating in any concomitant care or research trials
  • History of suffering from any mental/psychiatric disorders:

Suffering from a higher risk of burn out, indicated by a total score of more than 2.59 on the Burn out assessment tool (BAT) Suffering from high general fatigue, indicated by a score of more than 57 on the Multidimensional fatigue inventory (MFI) Suffering from depression, indicated by a score of more than16 on the Beck depression inventory-II (BDI-II)

  • Use of medication Chronic use with an exception for contraceptives Prescribed medication in between or before trials Use of non-prescribed occasional medication 24 hours prior each trial
  • Use of caffeine and heavy efforts 24 hours prior each trial
  • Suffering from colour vision deficiencies
  • Not eating a standardized meal, the morning of each trial

Treatment and study plan

Reboxetine Pill

Drug

8 mg

Methylphenidate Oral Product

Drug

20 mg

Primary outcomes

  1. Number of repetitions

    Time frame: 30 minutes

    Number of repetitions during knee extension task

  2. Electroencephalography (spectral analysis)

    Time frame: 80 minutes

    measurement of cortical activity with 64 channels (spectral density in alpha, beta, gamma, delta, theta)

  3. Electroencephalography (event related potentials)

    Time frame: 80 minutes

    measurement of cortical activity with 64 channels (event related potentials)

  4. Electromyography

    Time frame: 60 minutes

    Target muscles are rectus femoris and vastus lateralis (median frequency)

  5. Accuracy

    Time frame: 60 minutes

    Accuracy of correct answers during Stroop task

  6. Reaction time

    Time frame: 60 minutes

    Reaction time for answers during Stroop task

Secondary outcomes

  1. Perceived stress scale questionnaire (PSS-10)

    Time frame: 5 minites

    Result is the score of the questionnaire (may 40 points)

  2. the international physical activity questionnaire short form (IPAQ-SF)

    Time frame: 2 minutes

    Result is the score of the questionnaire

  3. The Brunel Mood Scale (BRUMS)

    Time frame: 5 minutes

    Result is the score of the questionnaire (each subscale max 0-16)

  4. Motivation with visual analog score (Moti-VAS)

    Time frame: 1 minute

    Result is the score between 0 and 100

  5. The National Aeronautics and Space Administration Task Load Index (NASA-TLX)

    Time frame: 3 minutes

    Result is the score of the questionnaire

  6. Subjective feeling of Mental Fatigue with visual analog score (M-VAS)

    Time frame: 1 minute

    Result is the score between 0 and 100

  7. Subjective feeling of physical fatigue with visual analog score (P-VAS)

    Time frame: 1 minute

    Result is the score between 0 and 100

  8. Karolinska Sleepiness Scale (KSS)

    Time frame: 5 minutes

    Result is the score of the questionnaire (max 24)

  9. Internal load of the physical performance (CR100 RPE)

    Time frame: 30 minutes

    Result is the score between 0 and 100

  10. Heart Rate

    Time frame: 60 minutes

    continuously assessed by using the POLAR H10 sensor

  11. Lactate concentration

    Time frame: 5 minutes

    blood lactate will be measured at the beginning and end of the trial at the finger tip of the participant (unit = mmol/L)

Study contacts

Contact information is provided by the study sponsor or research team.

Tjaša Ocvirk, Msc

CONTACT

[email protected]

+38631278074

Yahaira Laurisa Arenales Arauz, Msc

CONTACT

[email protected]

+31615076269

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Collaborators

  • Science and Research Centre Koper

Registry information

Official study title

Investigating Fundamental Mechanisms of Mental and Physical Fatigue Using Neurotransmitter Reuptake Inhibitors and Electroencephalography: a Randomized Counterbalanced Crossover Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 30, 2023
Registry last updated
Jun 18, 2025

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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