DepressionNCT04099056
Brain Stimulation and Decision-making
A study testing Neurostimulation in people with Depression, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2019to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Provides written informed consent
- Fluent English speaker
- Absence of current drug use as assessed by subject history and/or urine drug screen
Who cannot join
- 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
Show all 39Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
About this study
Official title: Brain Stimulation Studies of Decision-making Using Repetitive Transcranial Magnetic Stimulation (rTMS) and Temporal Interference (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.
Read the detailed description
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. Running in parallel, research involving neuromodulation has afforded researchers the opportunity to test the impact of direct stimulation on areas hypothesized to be involved in certain processes or behaviors. Among such technologies are transcranial magnetic stimulation (TMS) and temporal interference (TI).
TMS and TI can be performed during any sort of cognitive or behavioral task to estimate the effect of the stimulated brain area; as such, TMS and TI have an exciting array of potential applications in research. One area, for example, is cost-benefit decision-making. Because of the potential biases associated with self-report measures-including simple recall errors, misinterpretations of the item, and social-conformity pressures-a number of psychological laboratories have advocated for the use of decision-making tasks as an alternative means of assessing motivation and reward-related symptoms. Such tasks ask individuals to choose how much they are willing to work, wait, or risk to win various rewards. These measures have been used in a variety of behavioral and neuroimaging studies and in different clinical populations.
This study will use TMS or TI in combination with a series of behavioral tasks to probe the relationship between areas known or hypothesized to be involved in cognition and/or cost-benefit decision-making, and performance on these tasks. This study aims to understand the effect of TMS or TI stimulation of certain brain areas on performance in a series of cognition- and decision-based behavioral tasks. To do so, the researchers will stimulate areas of the cortex hypothesized to be selectively engaged with cognition of a given category, or cost-benefit decision-making (depending on the behavioral tasks used). This study will examine healthy controls and depressed patients to investigate these effects. Such an aim will not only provide a deeper understanding of decision-making for basic research but will also hopefully inform understanding when decision-making is altered, as in psychiatric populations.
- Conditions
- Depression
- Being tested
- Neurostimulation
- Keywords
- Transcranial magnetic stimulation (TMS), Temporal Interference (TI)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurostimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Major Depressive Disorder (MDD) | Active comparator | Participants with MDD will complete computer tasks while receiving TMS/ TI Receives: Device: Neurostimulation |
| Healthy Control | Active comparator | Participants without MDD will complete computer tasks while receiving TMS/TI Receives: Device: Neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, during TMS/ TI stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start11 Nov 2019
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Emory 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michael Treadway, Emory University
- Investigators
- Michael Treadway, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099056
- Sponsor's protocol ID
- IRB00110965
- Other IDs
- F31MH127911, 2025P011706
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2019
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Stimulation Studies of Decision-making Using Repetitive Transcranial Magnetic Stimulation (rTMS) and Temporal Interference (TI)
- ClinicalTrials.gov ID
- NCT04099056
- Acronym / sponsor ID
- IRB00110965
- Conditions
- Depression
- Keywords
- Transcranial magnetic stimulation (TMS), Temporal Interference (TI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 Sep 2019 (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.
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.
Detailed description
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. Running in parallel, research involving neuromodulation has afforded researchers the opportunity to test the impact of direct stimulation on areas hypothesized to be involved in certain processes or behaviors. Among such technologies are transcranial magnetic stimulation (TMS) and temporal interference (TI).
TMS and TI can be performed during any sort of cognitive or behavioral task to estimate the effect of the stimulated brain area; as such, TMS and TI have an exciting array of potential applications in research. One area, for example, is cost-benefit decision-making. Because of the potential biases associated with self-report measures-including simple recall errors, misinterpretations of the item, and social-conformity pressures-a number of psychological laboratories have advocated for the use of decision-making tasks as an alternative means of assessing motivation and reward-related symptoms. Such tasks ask individuals to choose how much they are willing to work, wait, or risk to win various rewards. These measures have been used in a variety of behavioral and neuroimaging studies and in different clinical populations.
This study will use TMS or TI in combination with a series of behavioral tasks to probe the relationship between areas known or hypothesized to be involved in cognition and/or cost-benefit decision-making, and performance on these tasks. This study aims to understand the effect of TMS or TI stimulation of certain brain areas on performance in a series of cognition- and decision-based behavioral tasks. To do so, the researchers will stimulate areas of the cortex hypothesized to be selectively engaged with cognition of a given category, or cost-benefit decision-making (depending on the behavioral tasks used). This study will examine healthy controls and depressed patients to investigate these effects. Such an aim will not only provide a deeper understanding of decision-making for basic research but will also hopefully inform understanding when decision-making is altered, as in psychiatric populations.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Major Depressive Disorder (MDD) | Active comparator | Device: NeurostimulationParticipants with MDD will complete computer tasks while receiving TMS/ TI |
| Healthy Control | Active comparator | Device: NeurostimulationParticipants without MDD will complete computer tasks while receiving TMS/TI |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provides written informed consent
- Fluent English speaker
- Absence of current drug use as assessed by subject history and/or urine drug screen
Key exclusion criteria (39 listed)
- 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
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 |
|---|---|---|
| NeurostimulationParticipants 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. | Device | Healthy Control, Participants with Major Depressive Disorder (MDD) |
Primary outcome
Staggered Effort-Based Decision-Making Task
Time frame: Day 1, during TMS/ TI stimulation
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Depression
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Recruiting
Understanding the Neural Underpinnings of Risk-Taking Behavior in Psychiatric Disease
Depression - Major Depressive Disorder
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
Major Depressive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
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.
Michael Treadway, PhD principal investigator
Emory 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 Neurostimulation in people with Depression, run by Emory 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 39 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: looking for participants now, as of the sponsor's last update on 10 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Treadway, PhD (404 727-3166, tread.lab.cbid@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staggered Effort-Based Decision-Making Task (time frame: Day 1, during TMS/ TI stimulation). 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 10 Dec 2025.