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RecruitingNCT05111223Updated Aug 19, 2024

Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making

An interventional study of Real transcranial magnetic stimulation (TMS) before conditioning and Real transcranial magnetic stimulation (TMS) before devaluation test in Healthy, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by Northwestern University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age between 18 and 40 years old
  • Right-handed
  • Fluent English speakers

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    TMS targeting OFC anterior networks

    Participants will receive TMS and sham targeting the OFC network.

    Device: Real transcranial magnetic stimulation (TMS) before conditioning · Device: Real transcranial magnetic stimulation (TMS) before devaluation test · Device: Sham transcranial magnetic stimulation (TMS)

  • 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 · Device: Real transcranial magnetic stimulation (TMS) before devaluation test · Device: Sham transcranial magnetic stimulation (TMS)

Interventions

  • DeviceReal 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.

  • DeviceReal 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.

  • DeviceSham 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.

06

What researchers measure

Primary outcomes

  1. Behavior on devaluation task

    Percentage of cues predicting non-devalued vs devalued odors chosen during the devaluation task.

    Time frame: 1 hour after intervention

  2. Resting-state functional magnetic resonance imaging

    Resting-state activity determined by functional magnetic resonance imaging.

    Time frame: 1 hour after intervention

07

Study locations

1 of 1 sites recruiting
  • Northwestern University
    Chicago, Illinois 60657, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All data that underlie results in a publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05111223
Lead sponsor
Northwestern University
Responsible party
Christina Zelano (Principal Investigator, Northwestern University) — Principal investigator
First posted
Nov 8, 2021
Start date
Jul 12, 2022
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Aug 19, 2024

Study contacts

Christina Zelano, PhD
Contact
c-zelano@northwestern.edu
312-503-4437
Greg Lane, PhD
Contact
312-503-7244
Christina Zelano, PhD
principal investigator · Assistant Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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