RecruitingNot applicable

Brain Stimulation and Decision-making

Brain Stimulation Studies of Decision-making Using Repetitive Transcranial Magnetic Stimulation (rTMS) and Temporal Interference (TI)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In recent years, countless studies have employed functional magnetic resonance imaging (fMRI) and other imaging modalities to both discover and track activity in brain regions involved in performance or behavior in a wide range of tasks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how brain stimulation affects hard choices in people with depression and people without depression. Participants do game-like tasks in a lab while receiving brain stimulation called TMS or TI.

Decision-making is an important process that is frequently shown to be impaired in patients with depression. While a number of preclinical and clinical studies have identified key regions involved in this process, it remains unclear exactly how these regions are influencing choice behavior especially when choices become more challenging. The goal of this project is to understand how these regions, such as the cingulate cortex, impact difficult choice behavior. Specifically, the researchers are interested in learning how disruptions in cognitive control might impact choice preferences during difficult decisions in depressed patients. To do this, this study will recruit participants with depression (as well as healthy controls) to perform game-like tasks in the laboratory while undergoing TMS or TI.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give written consent to join the study.
  • Speak English fluently.
  • Have no current drug use, based on your history and/or a urine test.

Who can't join

  • You are pregnant, breastfeeding, trying to become pregnant, or think you may be pregnant.
  • You cannot safely have a brain scan or brain stimulation, or cannot fit comfortably in the scanner. Reasons include certain metal implants or medical devices, past brain surgery, fear of tight spaces, or a personal or family history of epilepsy (a seizure disorder).
  • You take medicines that raise seizure risk or weaken the effects of brain stimulation. You have a past or current serious or unstable illness, or a head injury that caused more than a brief loss of consciousness.
  • You are not right-handed; have used cocaine, stimulants, or medicines that affect dopamine, a brain chemical; currently use tobacco or nicotine products; used them more than occasionally in the past year; or give answers with major inconsistencies.
  • For the optional EMA part: you have more than minimal suicide risk, a condition that could worsen with or prevent walking or running, a current psychotic disorder (which affects your sense of reality), bipolar disorder, or a severe substance use disorder. Use of mental health medicines in the past 6 weeks also excludes you.
  • For people with depression: more than minimal suicide risk; a depression test score of 11 or higher; or certain past or current mental health conditions. These include mental illness due to a medical condition, schizophrenia, delusions, other psychotic disorders, bipolar disorder, substance dependence, or substance abuse in the past year.
  • For people with depression, the listing also gives medicine-free periods: 6 weeks for fluoxetine, 6 months for antipsychotic medicines, and 2 weeks for benzodiazepines or other antidepressants. It lists these under exclusions, so ask the study team to clarify. No one will be asked to stop mental health medicines to join.
  • For healthy volunteers: any past or current mental health disorder, such a disorder in a parent, sibling, or child, or any past or current use of mental health medicines. The listing also excludes a depression test (BDI-II) score of 10 or lower and a pleasure test (SHAPS) score above 1.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Provides written informed consent * Fluent English speaker * Absence of current drug use as assessed by subject history and/or urine drug screen Exclusion Criteria: * Pregnant or currently breastfeeding women or any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant, as assessed by subject report and/or urine pregnancy screen * Contraindications to fMRI scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia) as assessed with the standard MRI screening form from the Facility for Research and Education in Neuroscience (FERN) * Unable to fit comfortably in the scanner * Contraindication to TMS, including history or family history of epilepsy, metallic implants in the head and/or neck, brain stimulators, vagus nerve stimulators, ventriculoperitoneal (VP) shunt, pacemakers * Current use of medications that may increase the risk of seizures (e.g., bupropion, varenicline, chlorpromazine, theophylline) or reduce the effects of rTMS, such as benzodiazepines * History or current serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease, as assessed by subject history * Not right-handed as assessed by the Chapman handedness inventory or self-report * History of head injury resulting in more than a brief loss of consciousness, as assessed by subject history * History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine), as assessed by subject history * History of use of dopaminergic drugs (including methylphenidate or other stimulant medication), as assessed by subject history * Current use or more than occasional use in the past year of tobacco products, including cigarettes, e-cigarettes, cigars, snuff, and chewing tobacco, or nicotine replacement products such as gum or patches, as assessed by subject history * Evidence of significant inconsistencies in self-report measures Additional Exclusion Criteria for Optional Ecological Momentary Assessment (EMA)Component for Subject Safety * Anything above minimal risk for suicide, as assessed during the clinical interview (SCID) at screening and the Columbia Suicide Severity Rating Scale (C-SSR). C-SSRS risk will be assessed as any score \> 3. * Any physical or neuropsychiatric conditions that may worsen/or prevent walking or running. Additional Exclusion Criteria for Optional Ecological Momentary Assessment (EMA)Component for Data Quality * Meet criteria for current psychotic disorders, bipolar disorders, or severe substance use disorders as assessed by the Mini International Neuropsychiatric Interview. * Used psychotropic medications within the last six weeks as assessed by subject history. Additional Exclusion Criteria for Participants with Major Depressive Disorder: * Anything above minimal risk for suicide, as assessed during the clinical interview (SCID) at screening and the Columbia Suicide Severity Rating Scale (C-SSRS) * A symptom severity score of at least 11, as assessed by the Beck Depression Inventory (BDI)-II * History or current diagnosis of any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV psychiatric illnesses: * Organic mental disorder * Schizophrenia spectrum disorders * Delusional disorder * Psychotic disorders not otherwise specified * Patients with mood-congruent or mood-incongruent psychotic features * Patients with bipolar mood disorders * Substance dependence * Substance abuse within the last 12 months (except cocaine or stimulant abuse), which will lead to exclusion * Absence of any psychotropic medications for at least 2 weeks. No patient will be asked to discontinue or otherwise interrupt any psychotropic medications to participate in this study. The listed "washout" periods are only applicable for patients who previously used psychotropic medications, but recently decided to discontinue their use for some other reason. * 6 weeks for fluoxetine * 6 months for neuroleptics * 2 weeks for benzodiazepines * 2 weeks for any other antidepressants Additional Exclusion Criteria for Healthy Controls: * Any current or past history of any DSM-IV psychiatric illnesses, presence of a DSM-IV psychiatric disorder within a first-degree relative, or current or past use of psychotropic medications * Score no greater than 10 on the BDI-II * Score \> 1 on the SHAPS

Study sites (1)

GA