NCT05111223

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy

Timeline
2mo left

Started Jul 2022

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2022Aug 2026

First Submitted

Initial submission to the registry

October 28, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

July 12, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

4.1 years

First QC Date

October 28, 2021

Last Update Submit

August 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Behavior on devaluation task

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

    1 hour after intervention

  • Resting-state functional magnetic resonance imaging

    Resting-state activity determined by functional magnetic resonance imaging.

    1 hour after intervention

Study Arms (2)

TMS targeting OFC anterior networks

EXPERIMENTAL

Participants will receive TMS and sham targeting the OFC network.

Device: Real transcranial magnetic stimulation (TMS) before conditioningDevice: Real transcranial magnetic stimulation (TMS) before devaluation testDevice: Sham transcranial magnetic stimulation (TMS)

Experimental: TMS targeting posterior OFC networks

EXPERIMENTAL

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

Device: Real transcranial magnetic stimulation (TMS) before conditioningDevice: Real transcranial magnetic stimulation (TMS) before devaluation testDevice: Sham transcranial magnetic stimulation (TMS)

Interventions

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.

Experimental: TMS targeting posterior OFC networksTMS targeting OFC anterior networks

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.

Experimental: TMS targeting posterior OFC networksTMS targeting OFC anterior networks

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 networksTMS targeting OFC anterior networks

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60657, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Christina Zelano, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Zelano, PhD

CONTACT

Greg Lane, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 8, 2021

Study Start

July 12, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

All data that underlie results in a publication

Time Frame
Upon publication
Access Criteria
Data can be obtained from PI for non-profit purposes upon reasonable request

Locations