Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05111223
Collaborator
(none)
60
2
17

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Real transcranial magnetic stimulation (TMS) before conditioning
  • Device: Real transcranial magnetic stimulation (TMS) before devaluation test
  • Device: Sham transcranial magnetic stimulation (TMS)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: TMS targeting anterior OFC networks

Participants will receive TMS and sham targeting the anterior 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: 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.

Outcome Measures

Primary Outcome Measures

  1. Behavior on devaluation task [1 hour after intervention]

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

  2. Resting-state functional magnetic resonance imaging [1 hour after intervention]

    Resting-state activity determined by functional magnetic resonance imaging.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Thorsten Kahnt, PhD, Associate Professor
  • Principal Investigator: Christina Zelano, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christina Zelano, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier:
NCT05111223
Other Study ID Numbers:
  • STU00216104
First Posted:
Nov 8, 2021
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 12, 2022