Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-30 @ 9:36 AM
Study NCT ID:
NCT07059533
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2025-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Training in Combination With Non-invasive Brain Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C068637', 'term': 'calcium D-pantothenate, L-cysteine drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'We randomly assigned participants to receive either real or placebo stimulation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-07-01', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor performance', 'timeFrame': 'From the start of the practice to the end of training at 5 days (and follow up on the 10th day and 60th day)', 'description': 'Replication of a nine-digit sequence displayed on a screen, as quickly and as accurately as possible, using the left hand'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-invasive brain stimulation', 'Transcranial direct current stimulation'], 'conditions': ['Motor Skill Acquisition in Healthy Older Adults']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to investigate the impact of non-invasive brain stimulation on motor skill acquisition in healthy individuals. Participants performed a motor task with non-invasive brain stimulation applied over the area of the brain where movements were controlled. The study compared motor skill performance between with the active stimulation and the placebo stimulation.', 'detailedDescription': 'This study implemented a randomized, double-blinded, and sham-controlled design, investigating the effects of non-invasive brain stimulation on motor skill acquisition in healthy individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age equals to or over 18 years old\n* absence of major neurological, psychiatric and physical impairment, with normal or corrected to normal vision\n* right handed\n* in good general health\n\nExclusion Criteria:\n\n* professional musicians/stenotypist\n* unable to consent\n* unable to perform the task as required (instructions and setup)\n* exclusion criteria for magnetic resonance imaging (MRI), transcranial electrical stimulation (tES), transcranial magnetic stimulation (TMS)'}, 'identificationModule': {'nctId': 'NCT07059533', 'acronym': 'TrainStim', 'briefTitle': 'Training in Combination With Non-invasive Brain Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Ecole Polytechnique Fédérale de Lausanne'}, 'officialTitle': 'Non-invasive Brain Stimulation to Enhance the Effects of Training in Healthy Old and Patients With Focal Brain Lesions', 'orgStudyIdInfo': {'id': '2017-00301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verum', 'description': 'anodal transcranial direct current stimulation', 'interventionNames': ['Other: Verum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '40 seconds of stimulation delivered at the beginning of training (with 8 seconds ramp-up and 5 seconds ramp-down times)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Verum', 'type': 'OTHER', 'description': 'anodal transcranial direct current stimulation: 20 minutes of stimulation with 1 mA (ramp-up/ramp-down times of 8 seconds)', 'armGroupLabels': ['Verum']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'anodal transcranial direct current stimulation with 40 seconds of stimulation delivered at the beginning of training (with 8 seconds ramp-up and 5 seconds ramp-down times)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1202', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Campus Biotech', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Friedhelm Hummel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Full professor', 'investigatorFullName': 'Friedhelm Hummel', 'investigatorAffiliation': 'Ecole Polytechnique Fédérale de Lausanne'}}}}