HealthyNCT05111223
Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making
A study testing Real transcranial magnetic stimulation (TMS) before conditioning and Real transcranial magnetic stimulation (TMS) before devaluation test 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 decision-making. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Real transcranial magnetic stimulation (TMS) before conditioning and Real transcranial magnetic stimulation (TMS) before devaluation test
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 31 Aug 2026
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 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, 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Greg Lane, PhD contact
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60657
Daria Porter, PhD, 312-503-4223, daria.porter@northwestern.edu
Christina Zelano, PhD
About this study
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.
- Conditions
- Healthy
- Being tested
- Real transcranial magnetic stimulation (TMS) before conditioning, Real transcranial magnetic stimulation (TMS) before devaluation test, Sham transcranial magnetic stimulation (TMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real transcranial magnetic stimulation (TMS) before conditioningDevice
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.
Real transcranial magnetic stimulation (TMS) before devaluation testDevice
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| TMS targeting OFC anterior networks | Experimental | Participants will receive TMS and sham targeting the OFC network. Receives: Device: Real transcranial magnetic stimulation (TMS) before conditioning; Device: Real transcranial magnetic stimulation (TMS) before devaluation test; Device: Sham transcranial magnetic stimulation (TMS) |
| Experimental: TMS targeting posterior OFC networks | Experimental | Participants will receive TMS and sham targeting the posterior OFC network. Receives: Device: Real transcranial magnetic stimulation (TMS) before conditioning; Device: Real transcranial magnetic stimulation (TMS) before devaluation test; Device: Sham transcranial magnetic stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior on devaluation task
Percentage of cues predicting non-devalued vs devalued odors chosen during the devaluation task.
Measured: 1 hour after intervention
Resting-state functional magnetic resonance imaging
Resting-state activity determined by functional magnetic resonance imaging.
Measured: 1 hour after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start12 Jul 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
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, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111223
- Sponsor's protocol ID
- STU00216104
- Status last verified
- Aug 2024
- First submitted
- 28 Oct 2021
- Last updated
- 19 Aug 2024
- 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making
- ClinicalTrials.gov ID
- NCT05111223
- Acronym / sponsor ID
- STU00216104
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 8 Nov 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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMS targeting OFC anterior networks | Experimental | Device: Real transcranial magnetic stimulation (TMS) before conditioning, Device: Real transcranial magnetic stimulation (TMS) before devaluation test, Device: Sham transcranial magnetic stimulation (TMS)Participants will receive TMS and sham targeting the OFC network. |
| Experimental: TMS targeting posterior OFC networks | Experimental | Device: Real transcranial magnetic stimulation (TMS) before conditioning, Device: Real transcranial magnetic stimulation (TMS) before devaluation test, Device: Sham transcranial magnetic stimulation (TMS)Participants will receive TMS and sham targeting the posterior OFC network. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 40 years old
- Right-handed
- Fluent English speakers
Key exclusion criteria (22 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, 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.)
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 |
|---|---|---|
| Real transcranial magnetic stimulation (TMS) before conditioningReal 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 | Experimental: TMS targeting posterior OFC networks, TMS targeting OFC anterior networks |
| Real transcranial magnetic stimulation (TMS) before devaluation testReal 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 | Experimental: TMS targeting posterior OFC networks, TMS targeting OFC anterior networks |
| 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 | Experimental: TMS targeting posterior OFC networks, TMS targeting OFC anterior networks |
Primary outcome
Behavior on devaluation task
Time frame: 1 hour after intervention
Percentage of cues predicting non-devalued vs devalued odors chosen during the devaluation task.
Resting-state functional magnetic resonance imaging
Time frame: 1 hour after intervention
Resting-state activity determined by functional magnetic resonance imaging.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: Yes. All data that underlie results in a publication
Related trials for Healthy
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
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.
Greg Lane, PhD contact
Christina Zelano, PhD principal investigator
Assistant Professor
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) before conditioning and Real transcranial magnetic stimulation (TMS) before devaluation test 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 22 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: status not confirmed, as of the sponsor's last update on 19 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Zelano, PhD (312-503-4437, c-zelano@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior on devaluation task (time frame: 1 hour after intervention). 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 19 Aug 2024.