NCT06633913 · Jing Jiang
Concurrent TMS-fMRI
What this study is about
The goal of this clinical trial is to examine the neural mechanisms underlying transcranial magnetic stimulation (TMS) using concurrent functional magnetic resonance imaging (fMRI) in both healthy controls (HCs) and patients with high negative affect symptoms, such as depression. Approximately half male and half female participants aged 18-65 will be recruited.
View original scientific description
The goal of this clinical trial is to examine the neural mechanisms underlying transcranial magnetic stimulation (TMS) using concurrent functional magnetic resonance imaging (fMRI) in both healthy controls (HCs) and patients with high negative affect symptoms, such as depression. Approximately half male and half female participants aged 18-65 will be recruited. The main questions it aims to answer are: 1. Is the acute/transient effect induced by single-pulse TMS related to the long-term modulatory effect induced by repetitive TMS (rTMS)? 2. Do any of these effects predict negative affect symptoms, such as depression? Participants will: 1. Complete several tests to assess their cognitive abilities and emotional states 2. Undergo several brain scans, including resting-state fMRI, structural MRI, diffusion tensor imaging (DTI), and task fMRI 3.
Interventions
DEVICE
spTMS-TBS-spTMS
This study uses fMRI in combination with single-pulse TMS (spTMS) and theta-burst stimulation (TBS) to determine if the two effects coming from each are related to one another, and if there will be changes in brain activity when undergoing spTMS that are induced by TBS. Additionally, by stimulating the dlPFC in both patients and healthy controls with this paradigm, researchers are able to specifically compare the after-TBS single-pulse TMS-evoked brain responses with before-TBS responses to observe if TBS will change neural pathways disrupted in those who display high negative affect (e.g. depression).
Primary outcome measures
Pre and Post TBS Modulation Effect Comparison
Time frame: Up To 10 Minutes
The primary outcome measure will be the modulation effect of TBS to the dlPFC, which is the difference between TMS-induced acute/transient effects before and after TBS. The acute/transient effects will be assessed through single-pulse TMS-induced fMRI blood oxygenation level-dependent (BOLD) responses. The difference in BOLD response before and after TBS (i.e., TBS modulation effect) will be assessed using paired t-tests reported with t and p values.
Difference in TBS Modulation Effect Across Comparison Groups
Time frame: Up to 10 Minutes
Another primary outcome measure is whether this TBS modulation effect is different between healthy controls and patients with high negative affect symptoms (e.g. depression). The difference will be assessed using independent t-tests reported with t and p values.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for patients:
- Diagnosis of major depressive disorder
- Age greater than or equal to 18 years
- Age less than or equal to 65 years
- Able to understand and consent for research participation
- English-speaking Inclusion for healthy controls:
- Report no lifetime psychiatric diagnosis and treatment
- scores on Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder Questionnaire (GAD-7) lower than 4
- Age greater than or equal to 18 years
- Age less than or equal to 65 years
- Able to understand and consent for research participation
- English-speaking
Exclusion criteria
- for all subjects:
- Age less than 18 years
- Age greater than 65 years
- With epilepsy or seizure disorder
- With implanted ferromagnetic equipment in their face or skull near the stimulation target MRI Exclusion criteria for all subjects:
- Implanted device including pacemaker, coronary stent, defibrillator, or neurostimulation device that is not MRI-compatible
- Metal in body including bullets, shrapnel, metal slivers
- Claustrophobia
- Uncontrolled high blood pressure
- Blood circulation problems
- Opiate medication, antihypertensive medication, or any medication that interferes with blood flow (interferes with fMRI recordings)
- Significant heart disease, such as atrial fibrillation
- Pregnancy in female participants
- Prior exposure to deep brain stimulation, rTMS, or tDCS (transcranial direct current stimulation) therapies
- History of neurological or cardiovascular disorders, brain surgery, radiation treatment, brain hemorrhage or tumor, stroke, or diabetes
- Significant traumatic brain injury (loss of consciousness, post-injury amnesia, significant radiological/neurological findings, penetrating brain injury)
- Refusal to abstain from illicit drug use for duration of the study
- Refusal to abstain from alcohol within 24 hours of scans If you would like to participate in the study, click this link to fill out the Screening Form: https://redcap.icts.uiowa.edu/redcap/surveys/?s=DEYHWF8TMCHHW4Y7. Kindly note that our research team will contact you directly only if you meet the eligibility criteria for the study. Due to the high volume of responses, we are unable to reply to individual inquiries or provide feedback about eligibility decisions.
Where
- Iowa City, Iowa
Collaborators
National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2026 · Source of record for eligibility and locations