Brussels Labo voor Inspanning & Topsport U-residence
Brussels, Brussels Capital, 1050, Belgium
Location status: Recruiting
Location contact
CONTACT
NCT Number: NCT05880342
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.
Interested in participating?
Request Info18 year–35 year
All sexes
Interventional
Phase 3
Brussels, Brussels Capital, 1050, Belgium
Location status: Recruiting
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
8 mg
20 mg
Time frame: 30 minutes
Number of repetitions during knee extension task
Time frame: 80 minutes
measurement of cortical activity with 64 channels (spectral density in alpha, beta, gamma, delta, theta)
Time frame: 80 minutes
measurement of cortical activity with 64 channels (event related potentials)
Time frame: 60 minutes
Target muscles are rectus femoris and vastus lateralis (median frequency)
Time frame: 60 minutes
Accuracy of correct answers during Stroop task
Time frame: 60 minutes
Reaction time for answers during Stroop task
Time frame: 5 minites
Result is the score of the questionnaire (may 40 points)
Time frame: 2 minutes
Result is the score of the questionnaire
Time frame: 5 minutes
Result is the score of the questionnaire (each subscale max 0-16)
Time frame: 1 minute
Result is the score between 0 and 100
Time frame: 3 minutes
Result is the score of the questionnaire
Time frame: 1 minute
Result is the score between 0 and 100
Time frame: 1 minute
Result is the score between 0 and 100
Time frame: 5 minutes
Result is the score of the questionnaire (max 24)
Time frame: 30 minutes
Result is the score between 0 and 100
Time frame: 60 minutes
continuously assessed by using the POLAR H10 sensor
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)
Contact information is provided by the study sponsor or research team.
Tjaša Ocvirk, Msc
CONTACT
Yahaira Laurisa Arenales Arauz, Msc
CONTACT
Vrije Universiteit Brussel
Other
Investigating Fundamental Mechanisms of Mental and Physical Fatigue Using Neurotransmitter Reuptake Inhibitors and Electroencephalography: a Randomized Counterbalanced Crossover Trial
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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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