Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-02 @ 10:59 AM
Study NCT ID:
NCT03893604
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2019-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of tDCS on High Level and Recreational Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The device is preprogrammed by a third party non participating in any element in the study. They then chose (using opaque envelopes) the treatment code for each participant'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, triple-blind, sham-controlled, crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-03-26', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Strength', 'timeFrame': 'Immediately after tDCS and sham', 'description': 'Peak strength (measured by the isokinetic machine) is measured after each of the 30 repetitions.\n\nPeak strength of the 30 repetitions will be measured, and how strength decreases throughout the test will be analysed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tDCS', 'Athlete', 'Isokinetic', 'Endurance', 'Fatigue'], 'conditions': ['Healthy', 'Athlete']}, 'descriptionModule': {'briefSummary': "Healthy recreational and high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of anodal tDCS or sham tDCS.\n\nThe primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps' endurance after each session", 'detailedDescription': "Recruitment :\n\nHealthy recreational and high level athletes will be recruited through social media and advertisements.\n\nEach subject came twice to the Liege University Hospitals' isokinetic lab. Each session began with strapping the subjet into the isokinetic machine, making sure that all the settings were adapted to the subject. Then, each subject received either anodal tDCS, of sham tDCS. Neither the evaluator or the subject knew which they were receiving. Immediately following tDCS, there was a warmup consisting of stationary bike, and an isokinetic warmup. Then, subjects' endurance was using a maximal isokinetic tests, at 30 maximal concentric and eccentric contractions at a speed of 180°/s."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For the "recreational" group at most 3 hours of sport a week\n* For the "athletic" group, at least 10 hours of sport a week\n* Right handed and footed\n\nExclusion Criteria:\n\n* One on the TSST (in high and relatively high risk sections)\n* Previous neurological or orthopedic pathologies affecting limbs'}, 'identificationModule': {'nctId': 'NCT03893604', 'briefTitle': 'Effects of tDCS on High Level and Recreational Athletes', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Comparing the Effects of tDCS on Endurance Parameters Between High Level and Recreational Athletes', 'orgStudyIdInfo': {'id': '2017-313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anodal tDCS', 'description': 'Subjects will receive 20min anodal tDCS', 'interventionNames': ['Device: tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'Subjects will receive 20 minutes of Sham anodal tDCS', 'interventionNames': ['Device: tDCS']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'otherNames': ['Non invasive brain stimulation'], 'description': '20 minutes of anodal tDCS (C3/FP2) 2mA or sham', 'armGroupLabels': ['Anodal tDCS', 'Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Liege Univeristy Hospital', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Stephen Bornheim, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liege University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Bornheim Stephen', 'investigatorAffiliation': 'University of Liege'}}}}