Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-08 @ 6:57 AM
Study NCT ID:
NCT04247334
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2020-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inhibitory Control: Effects of Modulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2020-01-24', 'studyFirstSubmitQcDate': '2020-01-28', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fMRI connectivity at rest', 'timeFrame': '2 weeks', 'description': 'Changes in resting state connectivity of the inhibitory control information'}, {'measure': 'fMRI connectivity during a stop signal task', 'timeFrame': '2 weeks', 'description': 'Changes in task-based connectivity on the stop signal task'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Young Adults']}, 'descriptionModule': {'briefSummary': 'Inhibitory control is relevant to many clinical disorders, including substance abuse/dependence, obsessive-compulsive disorder, and attention-deficit hyperactivity disorder. This proposal is designed to assess brain networks related to response inhibition in healthy young adults, and use neuromodulation to change these networks and behavioral performance on a response inhibition task. Having an understanding of the brain mechanisms involved in response inhibition may enable us to improve pre-existing treatments for disorders with inhibitory control difficulties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Low (\\<1sd below the mean on the BRIEF-Inhibit) or high (\\>1sd above the mean on BRIEF-Inhibit scale)\n2. English fluency to ensure comprehension of study measures and instructions.\n\nExclusion Criteria:\n\n1. Presence of medical conditions contraindicated for tDCS, including history of any known intracranial pathology, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, current pregnancy or women of childbearing age not using effective contraception, or any other serious medical conditions or health problems that would interfere with participation (e.g., skin condition)\n2. Inability to undergo MRI\n3. Current substance abuse disorder\n4. Currently prescribed psychiatric medications.\n5. Active mania or psychosis'}, 'identificationModule': {'nctId': 'NCT04247334', 'briefTitle': 'Inhibitory Control: Effects of Modulation', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'Brain Circuitry of Inhibitory Control: Effects of Modulation', 'orgStudyIdInfo': {'id': '1352651-9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Cautious Participants', 'description': 'Participants who have low scores on a self-report of inhibitory control abilities (BRIEF-Inhibit).'}, {'type': 'EXPERIMENTAL', 'label': 'Impulsive Participants- Active Stimulation', 'description': 'Participants who have high scores on a self-report of inhibitory control abilities (BRIEF-Inhibit) who are randomized to active stimulation.', 'interventionNames': ['Device: Transcranial direct current stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Impulsive Participants- Sham Stimulation', 'description': 'Participants who have high scores on a self-report of inhibitory control abilities (BRIEF-Inhibit) who are randomized to sham stimulation.', 'interventionNames': ['Device: Transcranial direct current stimulation']}], 'interventions': [{'name': 'Transcranial direct current stimulation', 'type': 'DEVICE', 'description': '20 minutes of 2 milliamp transcranial direct current stimulation', 'armGroupLabels': ['Impulsive Participants- Active Stimulation', 'Impulsive Participants- Sham Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Nicole McLaughlin, PhD', 'role': 'CONTACT', 'email': 'nmclaughlin@butler.org', 'phone': '4014556608'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}