NCT05880342 The Role of the Brain in Mental and Physical Fatigue
| NCT ID | NCT05880342 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vrije Universiteit Brussel |
| Condition | Fatigue |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2023-05-03 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 62 participants in total. It began in 2023-05-03 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05880342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Fatigue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05880342 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 62 participants.
Is NCT05880342 currently recruiting?
Yes, NCT05880342 is actively recruiting participants. Contact the research team at laurisa.arenales@vub.be for enrollment information.
Where is the NCT05880342 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT05880342 clinical trial?
NCT05880342 is sponsored by Vrije Universiteit Brussel. The trial plans to enroll 62 participants.