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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04926961
Other study ID # STU00214694
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 16, 2021
Est. completion date November 3, 2021

Study information

Verified date November 2023
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research study examines the contribution of orbitofrontal cortex (OFC) networks to learning reward identity expectations.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date November 3, 2021
Est. primary completion date November 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Sham transcranial magnetic stimulation (TMS)
Sham TMS will be applied using the MagVenture MagPro X100 stimulator with the placebo side of the Cool-B65 A/P coil.
Real transcranial magnetic stimulation (TMS)
Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil.

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of correct outcome predictions Percentage of correct outcome predictions in response to predictive cues during the reversal learning task. 1 hour
Primary Blood oxygen level-dependent (BOLD) responses Blood oxygen level-dependent (BOLD) responses measured using functional magnetic resonance imaging (fMRI) during the reversal learning task. 1 hour
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