- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04926961
Testing the Contribution of Orbitofrontal Cortex Networks to Reward Identity Learning
November 8, 2023 updated by: Christina Zelano, Northwestern University
This research study examines the contribution of orbitofrontal cortex (OFC) networks to learning reward identity expectations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age between 18 and 50 years old
- Right-handed
- Fluent English speakers
Exclusion Criteria:
- History of significant neurological conditions (e.g., epilepsy, dementia, multiple sclerosis, brain tumors, etc.)
- 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.)
- Significant medical illnesses (e.g., cancer, meningitis, chronic obstructive pulmonary disease, cardiovascular disease, etc.)
- Significant cerebrovascular risk factors (e.g., hypertension, diabetes, elevated cholesterol, etc.)
- Current use of psychoactive medications (e.g., barbiturates, benzodiazepines, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, citalopram, escitalopram, fluoxetine, diazepam, etc.)
- Smell or taste dysfunction
- History of significant allergies requiring hospitalization for treatment
- History of severe asthma requiring hospitalization for treatment
- Habitual smoking
- 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.)
- Electronic devices (e.g., implanted cardiac defibrillator, cardiac pacemaker, deep brain/spinal cord or nerve stimulator, internal electrodes/wires, medication infusion devices, etc.)
- History of metal working without proper eye protection, or injury with metal shrapnel or metal slivers
- Claustrophobia
- Pregnancy
- Predisposition to seizures (e.g., personal history of seizures, family history of seizures epilepsy, pregnancy, alcoholism, etc.)
- Use of medications that increase the likelihood of seizures (e.g., bupropion, citalopram, duloxetine, ketamine, gamma-hydroxybutyrate, etc.)
- History of surgical procedures performed on the brain or spinal cord
- History of severe head trauma followed by loss of consciousness
- History of fainting spells or syncope
- Hearing problems or tinnitus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sham stimulation first, then real stimulation
Participants will first be delivered sham TMS stimulation.
Then on a separate day, participants will be delivered real TMS stimulation.
|
Sham TMS will be applied using the MagVenture MagPro X100 stimulator with the placebo side of the Cool-B65 A/P coil.
Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil.
|
Experimental: Real stimulation first, then sham stimulation
Participants will first be delivered real TMS stimulation.
Then on a separate day, participants will be delivered sham TMS stimulation.
|
Sham TMS will be applied using the MagVenture MagPro X100 stimulator with the placebo side of the Cool-B65 A/P coil.
Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of correct outcome predictions
Time Frame: 1 hour
|
Percentage of correct outcome predictions in response to predictive cues during the reversal learning task.
|
1 hour
|
Blood oxygen level-dependent (BOLD) responses
Time Frame: 1 hour
|
Blood oxygen level-dependent (BOLD) responses measured using functional magnetic resonance imaging (fMRI) during the reversal learning task.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christina Zelano, PhD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 16, 2021
Primary Completion (Actual)
November 3, 2021
Study Completion (Actual)
November 3, 2021
Study Registration Dates
First Submitted
June 9, 2021
First Submitted That Met QC Criteria
June 14, 2021
First Posted (Actual)
June 15, 2021
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 8, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- STU00214694
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All data that underlie results in a publication
IPD Sharing Time Frame
Upon publication
IPD Sharing Access Criteria
Data can be obtained from PI for non-profit purposes upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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