Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making

This research study examines the contribution of orbitofrontal cortex (OFC) networks to decision-making.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: Real transcranial magnetic stimulation (TMS) before conditioning; Device: Real transcranial magnetic stimulation (TMS) before devaluation test; Device: Sham transcranial magnetic stimulation (TMS)

Detailed Description

This study will combine functional magnetic resonance imaging (fMRI), non-invasive transcranial magnetic stimulation (TMS), olfactory stimuli, and a devaluation task to define the specific contributions of orbitofrontal cortex (OFC) networks in outcome-guided behavior. We will use network-targeted TMS to modulate activity within anterior OFC and posterior OFC networks, examining if they have different contributions to decision-making. This is a randomized, between-subjects design.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Zelano, PhD; Phone Number: 312-503-4437; Email: c-zelano@northwestern.edu
• Study Contact Backup: Name: Greg Lane, PhD; Phone Number: 312-503-7244

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Recruiting
      • Northwestern University
      • Principal Investigator: Christina Zelano, PhD
      • Contact: Daria Porter, PhD; Phone Number: 312-503-4223; Email: daria.porter@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age between 18 and 40 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, substance use disorder, 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
• History of eating disorders (e.g., anorexia nervosa, bulimia nervosa, binge-eating disorder, etc.)
• Dieting or fasting
• 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 SR, 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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TMS targeting OFC anterior networks; Participants will receive TMS and sham targeting the OFC network.	Device: Real transcranial magnetic stimulation (TMS) before conditioning; Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil before the conditioning phase of the task.; Device: Real transcranial magnetic stimulation (TMS) before devaluation test; Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil before the devaluation test phase of the task.; 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.
Experimental: Experimental: TMS targeting posterior OFC networks; Participants will receive TMS and sham targeting the posterior OFC network.	Device: Real transcranial magnetic stimulation (TMS) before conditioning; Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil before the conditioning phase of the task.; Device: Real transcranial magnetic stimulation (TMS) before devaluation test; Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil before the devaluation test phase of the task.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior on devaluation task	Percentage of cues predicting non-devalued vs devalued odors chosen during the devaluation task.	1 hour after intervention
Resting-state functional magnetic resonance imaging	Resting-state activity determined by functional magnetic resonance imaging.	1 hour after intervention

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Christina Zelano, PhD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STU00216104

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