Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-07 @ 8:00 AM
Study NCT ID:
NCT03366233
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2017-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005222', 'term': 'Mental Fatigue'}], 'ancestors': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-04', 'studyFirstSubmitDate': '2017-12-01', 'studyFirstSubmitQcDate': '2017-12-01', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Oxygen Level Dependent - Signal during a 10-min cognitive task (i.e. Flanker task)', 'timeFrame': '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.', 'description': '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)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Fatigue', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '35964356', 'type': 'DERIVED', 'citation': "Van Cutsem J, Van Schuerbeek P, Pattyn N, Raeymaekers H, De Mey J, Meeusen R, Roelands B. A drop in cognitive performance, whodunit? Subjective mental fatigue, brain deactivation or increased parasympathetic activity? It's complicated! Cortex. 2022 Oct;155:30-45. doi: 10.1016/j.cortex.2022.06.006. Epub 2022 Jun 30."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy (No neurological/cardiorespiratory/psychological disorders)\n* No medication\n* Non-smoker\n* Between 18 and 35 years old\n\nExclusion Criteria:\n\n* Injuries\n* Illness\n* Pacemaker, neurostimulator, medication pump or metal implants\n* Use of medication or any kind of drugs\n* Use of alcohol, caffeine and heavy efforts 24 hours before each trial\n* Not eating the same meal the night before and the morning of each trial'}, 'identificationModule': {'nctId': 'NCT03366233', 'briefTitle': 'The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.', 'organization': {'class': 'OTHER', 'fullName': 'Vrije Universiteit Brussel'}, 'officialTitle': 'The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.', 'orgStudyIdInfo': {'id': 'MF-MRI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mentally fatiguing task', 'description': 'A modified Stroop task of 90 min, partitioned in 8 blocks of 252 stimuli, will be used as mentally fatiguing task.', 'interventionNames': ['Other: Mental fatigue']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control task', 'description': 'In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial for 90 min.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Mental fatigue', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Mentally fatiguing task']}, {'name': 'Control', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control task']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1050', 'city': 'Brussels', 'state': '(non-US)', 'country': 'Belgium', 'facility': 'Human Physiology and Sports Physiotherapy Research Group', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Romain Meeusen', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}