Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-29 @ 2:54 AM
Study NCT ID:
NCT04926961
Status:
COMPLETED
Last Update Posted:
2025-06-17
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Contribution of Orbitofrontal Cortex Networks to Reward Identity Learning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants receive both sham TMS stimulation and real TMS stimulation in different sessions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-15', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of correct outcome predictions', 'timeFrame': '1 hour', 'description': 'Percentage of correct outcome predictions in response to predictive cues during the reversal learning task.'}, {'measure': 'Blood oxygen level-dependent (BOLD) responses', 'timeFrame': '1 hour', 'description': 'Blood oxygen level-dependent (BOLD) responses measured using functional magnetic resonance imaging (fMRI) during the reversal learning task.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This research study examines the contribution of orbitofrontal cortex (OFC) networks to learning reward identity expectations.', 'detailedDescription': 'This study is designed to examine the contribution of OFC networks to reward identity learning. It will use network-targeted TMS to test whether OFC is necessary for reward identity learning. Healthy human subjects will perform a three-reward reversal learning task after either TMS or sham stimulation while fMRI data are acquired. This is a randomized, within-subject, cross-over study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 50 years old\n* Right-handed\n* Fluent English speakers\n\nExclusion Criteria:\n\n* History of significant neurological conditions (e.g., epilepsy, dementia, multiple sclerosis, brain tumors, etc.)\n* History of major psychiatric conditions (e.g., general anxiety disorder, depression, schizophrenia, obsessive-compulsive disorder, post-traumatic stress disorder, attention deficit hyperactivity disorder, alcoholism, etc.)\n* Significant medical illnesses (e.g., cancer, meningitis, chronic obstructive pulmonary disease, cardiovascular disease, etc.)\n* Significant cerebrovascular risk factors (e.g., hypertension, diabetes, elevated cholesterol, etc.)\n* Current use of psychoactive medications (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, citalopram, escitalopram, fluoxetine, diazepam, etc.)\n* Smell or taste dysfunction\n* History of significant allergies requiring hospitalization for treatment\n* History of severe asthma requiring hospitalization for treatment\n* Habitual smoking\n* Magnetic implants (e.g., shunts or stents, aneurysm clips, surgical clips, cochlear implants, metal bone/joint pins, plates and screws, eyelid spring or wires, etc.)\n* Electronic devices (e.g., implanted cardiac defibrillator, cardiac pacemaker, deep brain/spinal cord or nerve stimulator, internal electrodes/wires, medication infusion devices, etc.)\n* History of metal working without proper eye protection, or injury with metal shrapnel or metal slivers\n* Claustrophobia\n* Pregnancy\n* Predisposition to seizures (e.g., personal history of seizures, family history of seizures epilepsy, pregnancy, alcoholism, etc.)\n* Use of medications that increase the likelihood of seizures (e.g., bupropion, citalopram, duloxetine, ketamine, gamma-hydroxybutyrate, etc.)\n* History of surgical procedures performed on the brain or spinal cord\n* History of severe head trauma followed by loss of consciousness\n* History of fainting spells or syncope\n* Hearing problems or tinnitus'}, 'identificationModule': {'nctId': 'NCT04926961', 'briefTitle': 'Testing the Contribution of Orbitofrontal Cortex Networks to Reward Identity Learning', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Testing the Contribution of Orbitofrontal Cortex Networks to Reward Identity Learning', 'orgStudyIdInfo': {'id': 'STU00214694'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sham stimulation first, then real stimulation', 'description': 'Participants will first be delivered sham TMS stimulation. Then on a separate day, participants will be delivered real TMS stimulation.', 'interventionNames': ['Device: Sham transcranial magnetic stimulation (TMS)', 'Device: Real transcranial magnetic stimulation (TMS)']}, {'type': 'EXPERIMENTAL', 'label': 'Real stimulation first, then sham stimulation', 'description': 'Participants will first be delivered real TMS stimulation. Then on a separate day, participants will be delivered sham TMS stimulation.', 'interventionNames': ['Device: Sham transcranial magnetic stimulation (TMS)', 'Device: Real transcranial magnetic stimulation (TMS)']}], 'interventions': [{'name': 'Sham transcranial magnetic stimulation (TMS)', 'type': 'DEVICE', 'description': 'Sham TMS will be applied using the MagVenture MagPro X100 stimulator with the placebo side of the Cool-B65 A/P coil.', 'armGroupLabels': ['Real stimulation first, then sham stimulation', 'Sham stimulation first, then real stimulation']}, {'name': 'Real transcranial magnetic stimulation (TMS)', 'type': 'DEVICE', 'description': 'Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil.', 'armGroupLabels': ['Real stimulation first, then sham stimulation', 'Sham stimulation first, then real stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Christina Zelano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Upon publication', 'ipdSharing': 'YES', 'description': 'All data that underlie results in a publication', 'accessCriteria': 'Data can be obtained from PI for non-profit purposes upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Christina Zelano', 'investigatorAffiliation': 'Northwestern University'}}}}