Clinical trial NCT05111223: Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making
Official title: Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Behavior on devaluation task
timeFrame: 1 hour after intervention
measure: Resting-state functional magnetic resonance imaging
timeFrame: 1 hour after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Assistant Professor
name: Christina Zelano, PhD
role: PRINCIPAL_INVESTIGATOR
References: