Brain Stimulation and Decision-making

NCT04099056 | Recruiting FDA Device

• 3 other identifiers: IRB00110965F31MH1279112025P011706
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

Transcranial magnetic stimulation (TMS); Temporal Interference (TI)

Outcome Measures

Primary Outcomes (1)

• Staggered Effort-Based Decision-Making Task

  Assessment of reward motivation will be accomplished using an effort-based decision-making task modified for fMRI use. During each trial, subjects are presented with a choice between two levels of task difficulty, a High Effort option and a Low Effort option, which require different amounts of speeded manual button pressing for differing levels of monetary reward. The reward magnitude for a No Effort option remains constant ($1.00), while the reward magnitude for the High Effort option varies from $1.00 to $11.00. Additionally, the amount of effort required for the High Effort option will vary between 20%, 50%, 80% and 100% of the subject's max effort (set for each individual prior to scan). Multiple metrics of task performance will be compared between study arms.

  Day 1, during TMS/ TI stimulation

Study Arms (2)

Participants with Major Depressive Disorder (MDD)

ACTIVE COMPARATOR

Participants with MDD will complete computer tasks while receiving TMS/ TI

Device: Neurostimulation

Healthy Control

ACTIVE COMPARATOR

Participants without MDD will complete computer tasks while receiving TMS/TI

Device: Neurostimulation

Interventions

Neurostimulation DEVICE

Participants will be seated comfortably in a chair and asked to complete simple computer tasks. Participants will receive neurostimulation in the form of Transcranial Magnetic Stimulation (TMS) or Temporal Interference (TI). TMS: Either during, or just before any of the tasks, participants will receive either repetitive transcranial magnetic stimulation (rTMS) or single pulse TMS. During this, the researchers place a small plastic coil next to the participant's head. The coil will then generate a magnetic pulse, and stimulation will occur during presentation of the visual stimuli on which subjects will conduct behavioral or cognitive tasks. TI: Either during, or just before, any of the above tasks, participants will receive stimulation with TI. To do so, commercially available gel-based electrodes will be placed on the scalp to target the relevant brain region. The position targeted by the electrodes will be guided by previously defined coordinates.

Healthy Control; Participants with Major Depressive Disorder (MDD)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provides written informed consent
• Fluent English speaker
• Absence of current drug use as assessed by subject history and/or urine drug screen

You may not qualify if:

• 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
• 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.
• Meet criteria for current psychotic disorders, bipolar disorders, or severe substance use disorders as assessed by the Mini International Neuropsychiatric Interview.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Michael Treadway, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Treadway, PhD

CONTACT

404 727-3166; tread.lab.cbid@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 23, 2019
• Study Start: November 11, 2019
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)