Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making

Healthy Clinical Trial

Official title:

Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111223
• Other study ID #: STU00216104
• Status: Completed
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: April 18, 2023

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 18, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.
• 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.

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