Recruiting

TMS-fMRI

Sponsor:

Jing Jiang

Code:

NCT06633913

Conditions

Healthy Control

Depression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

spTMS-TBS-spTMS

Study Details

Brief summary:

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. Have two different types of TMS sequences, single-pulse and repetitive pulses, administered to specific brain regions while undergoing fMRI

Conditions

Healthy Control

Depression

Study ID

NCT06633913

Start date

Apr 19, 2024

Status verified date

Mar, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion 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 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.

Study Design

Enrollment

97 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: spTMS-TBS-spTMS

This is an open-label, single-arm study. The intervention will be delivered in spTMS-TBS-spTMS order to the dorsolateral prefrontal cortex (dlPFC) and vertex for each participant as described in the "Interventions" section. The order of the stimulation sites will be counterbalanced across participants.

Interventions

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 measure

  • Pre and Post TBS Modulation Effect Comparison [ Time Frame: Up To 10 Minutes ]
  • Difference in TBS Modulation Effect Across Comparison Groups [ Time Frame: Up to 10 Minutes ]

Central Contacts and Locations

Central contacts

Jing Jiang, PHD

319-678-3410TMS-fMRI-Study@uiowa.edu

Emily Gittle, BS

319-678-7043TMS-fMRI-Study@uiowa.edu

Locations

University of Iowa Carver College of Medicine

Recruiting

Iowa City, Iowa, United States, 52242

More Information

Sponsor

Jing Jiang

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • Depression
  • TMS
  • fMRI
  • TMS-fMRI
  • TBS
  • Functional Connectivity
  • Individual Differences
  • Mood Disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Jing Jiang on 2026-03-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.