120 Participants Needed
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Testing the Contribution of Orbitofrontal Cortex Networks to Decision-making in Healthy Subjects

Recruiting in Chicago (>99 mi)
DP
TK
CZ
GL
Overseen ByGreg Lane, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

Yes, if you are currently using psychoactive medications or medications that increase the likelihood of seizures, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of this treatment?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can influence decision-making and mood by affecting brain areas like the prefrontal cortex. For example, rTMS has been found to improve attentional control and response inhibition, which are important for decision-making. Additionally, the placebo effect in brain stimulation studies highlights the importance of expectation in perceived treatment benefits.12345

Is transcranial magnetic stimulation (TMS) safe for humans?

Research shows that transcranial magnetic stimulation (TMS), including its variations like repetitive TMS (rTMS) and sham TMS, is generally safe and well-tolerated in humans. Some studies have noted side effects, but these are typically mild and include things like headaches or scalp discomfort.46789

How does transcranial magnetic stimulation (TMS) differ from other treatments for decision-making processes?

Transcranial magnetic stimulation (TMS) is unique because it uses magnetic fields to stimulate specific areas of the brain, like the orbitofrontal cortex, to influence decision-making processes. Unlike traditional treatments that might involve medication, TMS is non-invasive and directly targets brain activity, potentially altering how decisions are made by affecting neural networks involved in risk-taking and valuation.45101112

Research Team

CZ

Christina Zelano, PhD

Principal Investigator

Assistant Professor

Eligibility Criteria

This trial is for healthy individuals aged 18-40, right-handed, fluent in English. It's not suitable for those on seizure-risk meds, with a history of fainting or eating disorders, metal implants, significant illnesses like cancer or heart disease, severe allergies or asthma requiring hospitalization, habitual smokers, hearing issues, claustrophobia, high stroke risk factors (like hypertension), psychoactive medication users or major psychiatric conditions.

Inclusion Criteria

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

Exclusion Criteria

You are taking medications that can increase the risk of seizures.
You have a history of fainting or passing out.
You have a history of eating disorders like anorexia nervosa, bulimia nervosa, or binge-eating disorder.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TMS targeting either anterior or posterior OFC networks, combined with fMRI and olfactory stimuli

1 session
1 visit (in-person)

Follow-up

Participants are monitored for decision-making behavior and resting-state activity after intervention

1 hour
1 visit (in-person)

Treatment Details

Interventions

  • Real transcranial magnetic stimulation (TMS) before conditioning
  • Real transcranial magnetic stimulation (TMS) before devaluation test
  • Sham transcranial magnetic stimulation (TMS)
Trial OverviewThe study tests how the orbitofrontal cortex influences decision-making using transcranial magnetic stimulation (TMS). Participants will receive real TMS before conditioning and devaluation tests to assess their decision-making process compared to sham TMS which serves as a control condition.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: TMS targeting OFC anterior networksExperimental Treatment3 Interventions
Participants will receive TMS and sham targeting the OFC network.
Group II: Experimental: TMS targeting posterior OFC networksExperimental Treatment3 Interventions
Participants will receive TMS and sham targeting the posterior OFC network.

Real transcranial magnetic stimulation (TMS) before conditioning is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as TMS for:
  • Major depressive disorder
  • Obsessive-compulsive disorder
  • Migraines
  • Smoking cessation
🇪🇺
Approved in European Union as TMS for:
  • Major depressive disorder
  • Obsessive-compulsive disorder
🇨🇦
Approved in Canada as TMS for:
  • Major depressive disorder
  • Obsessive-compulsive disorder

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Findings from Research

In a study with 10 normal volunteers, rapid-rate transcranial magnetic stimulation (rTMS) did not produce overall mood changes, but it did show that stimulation of the left prefrontal cortex increased feelings of sadness and decreased feelings of happiness compared to stimulation of the right prefrontal and midfrontal areas.
These findings suggest that different areas of the prefrontal cortex have distinct effects on mood, highlighting the importance of lateralized brain function in emotional regulation.
Lateralized effect of rapid-rate transcranial magnetic stimulation of the prefrontal cortex on mood.Pascual-Leone, A., Catalá, MD., Pascual-Leone Pascual, A.[2023]
High-frequency repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex improved response inhibition in healthy young men, as evidenced by fewer commission errors during attention tasks compared to sham stimulation.
The study involved 17 participants and suggests that rTMS may enhance attentional control, indicating potential therapeutic applications for conditions related to attentional deficits.
Acute high-frequency rTMS of the left dorsolateral prefrontal cortex and attentional control in healthy young men.Hwang, JH., Kim, SH., Park, CS., et al.[2019]
In patients with Parkinson's disease, the expectation of benefit from sham rTMS (placebo-rTMS) led to significant changes in dopamine neurotransmission, as indicated by a reduction in [11C] raclopride binding potentials in the striatum, suggesting a strong placebo effect.
This study highlights the need for placebo-controlled trials in rTMS research, as it demonstrates that even sham treatments can induce measurable changes in brain function, which could impact the interpretation of clinical outcomes.
Therapeutic application of transcranial magnetic stimulation in Parkinson's disease: the contribution of expectation.Strafella, AP., Ko, JH., Monchi, O.[2023]

References

Lateralized effect of rapid-rate transcranial magnetic stimulation of the prefrontal cortex on mood. [2023]
Acute high-frequency rTMS of the left dorsolateral prefrontal cortex and attentional control in healthy young men. [2019]
Therapeutic application of transcranial magnetic stimulation in Parkinson's disease: the contribution of expectation. [2023]
Diminished Risk-Aversion After Right DLPFC Stimulation: Effects of rTMS on a Risky Ball Throwing Task. [2020]
Effects of repetitive transcranial magnetic stimulation on non-veridical decision making. [2019]
Safety, Tolerability, and Nocebo Phenomena During Transcranial Magnetic Stimulation: A Systematic Review and Meta-Analysis of Placebo-Controlled Clinical Trials. [2022]
Sham or real--post hoc estimation of stimulation condition in a randomized transcranial magnetic stimulation trial. [2015]
Sham TMS: intracerebral measurement of the induced electrical field and the induction of motor-evoked potentials. [2022]
Repetitive transcranial magnetic stimulation influences mood in healthy male volunteers. [2022]
Transcranial direct current stimulation (tDCS) over the orbitofrontal cortex reduces delay discounting. [2023]
Repetitive transcranial magnetic stimulation over the right dorsolateral prefrontal cortex decreases valuations during food choices. [2010]
12.United Statespubmed.ncbi.nlm.nih.gov
Lateral prefrontal cortex and self-control in intertemporal choice. [2022]