Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making

NCT ID: NCT05111223

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2026-08-31

Brief Summary

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

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

TMS targeting OFC anterior networks

Participants will receive TMS and sham targeting the OFC network.

Group Type: EXPERIMENTAL

Real transcranial magnetic stimulation (TMS) before conditioning

Intervention Type: DEVICE

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.

Real transcranial magnetic stimulation (TMS) before devaluation test

Intervention Type: DEVICE

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.

Sham transcranial magnetic stimulation (TMS)

Intervention Type: DEVICE

Sham TMS will be applied using the MagVenture MagPro X100 stimulator with the placebo side of the Cool-B65 A/P coil.

Experimental: TMS targeting posterior OFC networks

Participants will receive TMS and sham targeting the posterior OFC network.

Group Type: EXPERIMENTAL

Real transcranial magnetic stimulation (TMS) before conditioning

Intervention Type: DEVICE

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.

Real transcranial magnetic stimulation (TMS) before devaluation test

Intervention Type: DEVICE

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.

Sham transcranial magnetic stimulation (TMS)

Intervention Type: DEVICE

Sham TMS will be applied using the MagVenture MagPro X100 stimulator with the placebo side of the Cool-B65 A/P coil.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Christina Zelano

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Zelano, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christina Zelano, PhD

Role: CONTACT

c-zelano@northwestern.edu

312-503-4437

Greg Lane, PhD

Role: CONTACT

312-503-7244

Facility Contacts

Daria Porter, PhD

Role: primary

daria.porter@northwestern.edu

312-503-4223

Other Identifiers

STU00216104

Identifier Type: -

Identifier Source: org_study_id