HealthyNCT04926961
Testing the Contribution of Orbitofrontal Cortex Networks to Reward Identity Learning
A study testing Real transcranial magnetic stimulation (TMS) in people with Healthy, run by Northwestern University at 1 site in United States.
Trial summary
This research study examines the contribution of orbitofrontal cortex (OFC) networks to learning reward identity expectations. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Real transcranial magnetic stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2021to 3 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 50 years old
- Right-handed
- Fluent English speakers
Who cannot join
- 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, alcoholism, 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
Show all 20Show fewer
- History of significant allergies requiring hospitalization for treatment
- History of severe asthma requiring hospitalization for treatment
- Habitual smoking
- 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, 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
Trial locations and contacts
1 site in 1 country.
About this study
This research study examines the contribution of orbitofrontal cortex (OFC) networks to learning reward identity expectations.
Read the detailed description
This study is designed to examine the contribution of OFC networks to reward identity learning. It will use network-targeted TMS to test whether OFC is necessary for reward identity learning. Healthy human subjects will perform a three-reward reversal learning task after either TMS or sham stimulation while fMRI data are acquired. This is a randomized, within-subject, cross-over study.
- Conditions
- Healthy
- Being tested
- Sham transcranial magnetic stimulation (TMS), Real transcranial magnetic stimulation (TMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham transcranial magnetic stimulation (TMS)Device
Sham TMS will be applied using the MagVenture MagPro X100 stimulator with the placebo side of the Cool-B65 A/P coil.
Real transcranial magnetic stimulation (TMS)Device
Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil.
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation first, then real stimulation | Experimental | Participants will first be delivered sham TMS stimulation. Then on a separate day, participants will be delivered real TMS stimulation. Receives: Device: Sham transcranial magnetic stimulation (TMS); Device: Real transcranial magnetic stimulation (TMS) |
| Real stimulation first, then sham stimulation | Experimental | Participants will first be delivered real TMS stimulation. Then on a separate day, participants will be delivered sham TMS stimulation. Receives: Device: Sham transcranial magnetic stimulation (TMS); Device: Real transcranial magnetic stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of correct outcome predictions
Percentage of correct outcome predictions in response to predictive cues during the reversal learning task.
Measured: 1 hour
Blood oxygen level-dependent (BOLD) responses
Blood oxygen level-dependent (BOLD) responses measured using functional magnetic resonance imaging (fMRI) during the reversal learning task.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start16 Jun 2021
- Primary completion3 Nov 2021
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants receive both sham TMS stimulation and real TMS stimulation in different sessions.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Zelano, Northwestern University
- Investigators
- Christina Zelano, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926961
- Sponsor's protocol ID
- STU00214694
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2021
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Contribution of Orbitofrontal Cortex Networks to Reward Identity Learning
- ClinicalTrials.gov ID
- NCT04926961
- Acronym / sponsor ID
- STU00214694
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study examines the contribution of orbitofrontal cortex (OFC) networks to learning reward identity expectations.
Detailed description
This study is designed to examine the contribution of OFC networks to reward identity learning. It will use network-targeted TMS to test whether OFC is necessary for reward identity learning. Healthy human subjects will perform a three-reward reversal learning task after either TMS or sham stimulation while fMRI data are acquired. This is a randomized, within-subject, cross-over study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants receive both sham TMS stimulation and real TMS stimulation in different sessions.
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation first, then real stimulation | Experimental | Device: Sham transcranial magnetic stimulation (TMS), Device: Real transcranial magnetic stimulation (TMS)Participants will first be delivered sham TMS stimulation. Then on a separate day, participants will be delivered real TMS stimulation. |
| Real stimulation first, then sham stimulation | Experimental | Device: Sham transcranial magnetic stimulation (TMS), Device: Real transcranial magnetic stimulation (TMS)Participants will first be delivered real TMS stimulation. Then on a separate day, participants will be delivered sham TMS stimulation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 50 years old
- Right-handed
- Fluent English speakers
Key exclusion criteria (20 listed)
- 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, alcoholism, 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Real stimulation first, then sham stimulation, Sham stimulation first, then real stimulation |
| Real transcranial magnetic stimulation (TMS)Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil. | Device | Real stimulation first, then sham stimulation, Sham stimulation first, then real stimulation |
Primary outcome
Percentage of correct outcome predictions
Time frame: 1 hour
Percentage of correct outcome predictions in response to predictive cues during the reversal learning task.
Blood oxygen level-dependent (BOLD) responses
Time frame: 1 hour
Blood oxygen level-dependent (BOLD) responses measured using functional magnetic resonance imaging (fMRI) during the reversal learning task.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: Yes. All data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Zelano, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real transcranial magnetic stimulation (TMS) in people with Healthy, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of correct outcome predictions (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.