Concurrent TMS-fMRI

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Jing Jiang
Study ID
NCT06633913
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • spTMS-TBS-spTMS — DEVICE
    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).

Study Details

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

Key Dates

Start date
Apr 19, 2024
Status verified
Mar 2026
Primary completion
Mar 1, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
97 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Pre and Post TBS Modulation Effect Comparison [ Time Frame: Up To 10 Minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Carver College of MedicineIowa CityIowa52242-

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