Health TrialsbyHealthPanel

Concurrent TMS-fMRI

ConditionsHealthy ControlDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJing Jiang

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

97 Participants
are divided into 1 treatment group
Group A: spTMS-TBS-spTMSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pre and Post TBS Modulation Effect Comparison

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.

Time frame
Up To 10 Minutes
2

Difference in TBS Modulation Effect Across Comparison Groups

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.

Time frame
Up to 10 Minutes

Secondary outcomes

1

TMS Effects with Neurocognitive and Emotion Functions

The secondary outcome measure is the relationship between the TBS modulation effect, TMS-induced acute/transient effects, intrinsic network properties, and participants' neurocognitive and emotion functions. This relationship will be assessed using the Pearson correlation reported using r and p values. The intrinsic network properties will be assessed by participants' (1) resting-state fMRI-based functional connectivity reported with Pearson based r values between two brain regions, (2) DTI MRI-based structural connectivity reported by the number of white matter streamlines. The neurocognitive functions will be assessed with cognitive scales and questionnaires (e.g. Montreal Cognitive Assessment (MOCA)). The emotion functions will be assessed emotional scales and questionnaires (e.g. Montgomery-Åsberg Depression Rating Scale (MADRS)).

Time frame
One Week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jing Jiang

Lead sponsor

University of Iowa

Sponsor institution

National Institutes of Health (NIH)

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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