RecruitingNot ApplicableNCT06633913

Concurrent TMS-fMRI

Neural Effects of Transcranial Magnetic Stimulation Using Concurrent Functional Magnetic Resonance Imaging

Sponsor

Jing Jiang

Enrollment

97 participants

Start Date

Apr 19, 2024

Study Type

INTERVENTIONAL

Conditions

Depression Healthy Control

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria18

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

Exclusion Criteria14

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.

Interventions

DEVICEspTMS-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).