Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT03249961
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2017-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Many Days Would You Want to Practice a Skill to Achieve it?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}, {'id': 'D050781', 'term': 'Transcranial Magnetic 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'}, {'id': 'D055909', 'term': 'Magnetic Field Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-23', 'studyFirstSubmitDate': '2017-08-02', 'studyFirstSubmitQcDate': '2017-08-14', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy', 'timeFrame': 'Up to 8 days', 'description': 'Accuracy is defined as the proportion of trials per block with hits to all targets in the correct sequence order.'}, {'measure': 'Speed', 'timeFrame': 'Up to 8 days', 'description': 'Speed is captured by the average sequence movement time per training block'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['motor', 'transcranial direct current stimulation', 'transcranial magnetic stimulation'], 'conditions': ['Motor Learning']}, 'descriptionModule': {'briefSummary': "Practice is required to improve your shot in basketball or to play a musical instrument. The learning of these motor skills can be further enhanced by non-invasively stimulating regions of the brain that control movements with electrical currents. These electric currents can strengthen or weaken connections of the brain, which consequently affects a person's ability to improve their performance on a skill. Non-invasive brain stimulation (NIBS) is widely applied in many disciplines of neuroscience research, and has potential therapeutic application. There are two specific types of NIBS that will be used in this research study: 1) Transcranial Direct Current Stimulation (tDCS), which applies very weak electrical currents via two rubber electrodes on the scalp, and 2) Transcranial Magnetic Stimulation (TMS), which applies magnetic pulses via a coil against the head, to stimulate regions of the brain. Both types of non-invasive brain stimulation (i.e., tDCS, and TMS) are well-tolerated, painless, and safe. The application of tDCS to brain regions that control movements, concurrently with practice of a skill, results in better skill performance, than practice alone with no tDCS. Therefore, in this study, we will be testing different types of brain stimulation and different amounts of practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n\nExclusion Criteria:\n\n* prior history of neurological or psychiatric disease\n* prior experience with the motor task used\n* contraindications to TMS and TDCS (e.g., metal implants, history of seizures and headaches)\n* musculoskeletal injury to upper limb\n* drugs that interact with NIBS (e.g., antidepressants, antipsychotics, anticonvulsants)'}, 'identificationModule': {'nctId': 'NCT03249961', 'briefTitle': 'How Many Days Would You Want to Practice a Skill to Achieve it?', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'How Many Days Would You Want to Practice a Skill to Achieve it?', 'orgStudyIdInfo': {'id': '175-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo Brain stimulation', 'description': 'Participants will receive Sham TDCS, and Transcranial Magnetic Stimulation (TMS)', 'interventionNames': ['Device: Sham TDCS', 'Device: Transcranial Magnetic Stimulation (TMS)']}, {'type': 'EXPERIMENTAL', 'label': 'Excitatory Brain Stimulation', 'description': 'Participants will receive Anodal TDCS, and Transcranial Magnetic Stimulation (TMS)', 'interventionNames': ['Device: Anodal TDCS', 'Device: Transcranial Magnetic Stimulation (TMS)']}], 'interventions': [{'name': 'Sham TDCS', 'type': 'DEVICE', 'description': 'Placebo stimulation is applied to the left motor cortex while participants perform a motor task in the right hand. During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.', 'armGroupLabels': ['Placebo Brain stimulation']}, {'name': 'Anodal TDCS', 'type': 'DEVICE', 'description': 'Excitatory stimulation is applied to the left motor cortex while participants perform a motor task in the right hand. During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.', 'armGroupLabels': ['Excitatory Brain Stimulation']}, {'name': 'Transcranial Magnetic Stimulation (TMS)', 'type': 'DEVICE', 'description': 'Participants will receive Transcranial Magnetic Stimulation (TMS) to allow research investigators to determine the location of the left motor cortex.', 'armGroupLabels': ['Excitatory Brain Stimulation', 'Placebo Brain stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Joyce Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}