Concurrent TMS-fMRI

NCT06633913 | Recruiting FDA Device

• 2 other identifiers: 202402416R01MH136197
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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. 1.Is the acute/transient effect induced by single-pulse TMS related to the long-term modulatory effect induced by repetitive TMS (rTMS)?
2. 2.Do any of these effects predict negative affect symptoms, such as depression?
3. 3.Complete several tests to assess their cognitive abilities and emotional states
4. 4.Undergo several brain scans, including resting-state fMRI, structural MRI, diffusion tensor imaging (DTI), and task fMRI
5. 5.Have two different types of TMS sequences, single-pulse and repetitive pulses, administered to specific brain regions while undergoing fMRI

Conditions

Healthy Control; Depression

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Up To 10 Minutes

• 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.

  Up to 10 Minutes

Secondary Outcomes (1)

• TMS Effects with Neurocognitive and Emotion Functions

  One Week

Study Arms (1)

spTMS-TBS-spTMS

EXPERIMENTAL

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.

Device: spTMS-TBS-spTMS

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).

spTMS-TBS-spTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jing Jiang: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Iowa Carver College of Medicine

Iowa City, Iowa, 52242, United States

RECRUITING

Related Publications (8)

• Mueller JK, Grigsby EM, Prevosto V, Petraglia FW 3rd, Rao H, Deng ZD, Peterchev AV, Sommer MA, Egner T, Platt ML, Grill WM. Simultaneous transcranial magnetic stimulation and single-neuron recording in alert non-human primates. Nat Neurosci. 2014 Aug;17(8):1130-6. doi: 10.1038/nn.3751. Epub 2014 Jun 29.

  PMID: 24974797 BACKGROUND

• Kobayashi M, Pascual-Leone A. Transcranial magnetic stimulation in neurology. Lancet Neurol. 2003 Mar;2(3):145-56. doi: 10.1016/s1474-4422(03)00321-1.

  PMID: 12849236 BACKGROUND

• Khedr EM, Rothwell JC, Ahmed MA, El-Atar A. Effect of daily repetitive transcranial magnetic stimulation for treatment of tinnitus: comparison of different stimulus frequencies. J Neurol Neurosurg Psychiatry. 2008 Feb;79(2):212-5. doi: 10.1136/jnnp.2007.127712.

  PMID: 18202212 BACKGROUND

• Hosomi K, Shimokawa T, Ikoma K, Nakamura Y, Sugiyama K, Ugawa Y, Uozumi T, Yamamoto T, Saitoh Y. Daily repetitive transcranial magnetic stimulation of primary motor cortex for neuropathic pain: a randomized, multicenter, double-blind, crossover, sham-controlled trial. Pain. 2013 Jul;154(7):1065-72. doi: 10.1016/j.pain.2013.03.016. Epub 2013 Mar 15.

  PMID: 23623156 BACKGROUND

• George MS. Whither TMS: A One-Trick Pony or the Beginning of a Neuroscientific Revolution? Am J Psychiatry. 2019 Nov 1;176(11):904-910. doi: 10.1176/appi.ajp.2019.19090957.

  PMID: 31672044 BACKGROUND

• Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.

  PMID: 32252538 BACKGROUND

• Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.

  PMID: 29726344 BACKGROUND

• Blumberger DM, Fitzgerald PB, Mulsant BH, Daskalakis ZJ. Repetitive transcranial magnetic stimulation for refractory symptoms in schizophrenia. Curr Opin Psychiatry. 2010 Mar;23(2):85-90. doi: 10.1097/YCO.0b013e3283366657.

  PMID: 20061953 BACKGROUND

MeSH Terms

Conditions

Depression; Mood Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Jing Jiang, PHD

CONTACT

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

Emily Gittle, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 9, 2024
• Study Start: April 19, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)