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RECRUITING

NCT06633913

Concurrent TMS-fMRI

Sponsor: Jing Jiang

View on ClinicalTrials.gov

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

Official title: Neural Effects of Transcranial Magnetic Stimulation Using Concurrent Functional Magnetic Resonance Imaging

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-04-19

Completion Date

2029-01-31

Last Updated

2026-03-12

Healthy Volunteers

Yes

Conditions

Healthy Control Depression

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).

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.

Locations (1)

University of Iowa Carver College of Medicine

Iowa City, Iowa, United States