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The Role of the Brain in Mental and Physical Fatigue

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 18, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary and study completion dates: Mar 2025 to Dec 31, 2025
    • Site details revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05880342
Lead Sponsor Vrije Universiteit Brussel
Collaborators: Science and Research Centre Koper
Conditions
(from sponsor)
Fatigue
Related terms Fatigue
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov