Completed

TMScogModTheta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State

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What is being tested

TMS

+ n-back working memory task

DeviceBehavioral
Who is being recruted

From 18 to 50 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: November 2019
See protocol details

Summary

Principal SponsorUniversity of Michigan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 11, 2019

Actual date on which the first participant was enrolled.

We will test the broad hypothesis that when TBS is applied during a controlled mental state, network changes will be facilitated, compared to stimulation when mental state is uncontrolled. We will focus on the dorsolateral prefrontal cortex (dlPFC) and the associated fronto-parietal network (FPN), which subserves cognitive control -- the ability to flexibly adapt and regulate behavior, an ability known to be impaired in neuropsychiatric conditions such as depression and dementia. We will use an 'n-back' task tapping cognitive control and the FPN. We will employ a within-subjects design with 40 healthy subjects in 4 MRI sessions. Each MRI session will consist of blood oxygenation level-dependent (BOLD) fMRI during an n-back task, resting state BOLD fMRI to measure connectivity and resting state arterial spin labeling (ASL) MRI to measure cerebral blood flow (rCBF) and examine effects on resting activity level. BOLD activation during the n-back will identify the FPN and the target site for dlPFC TBS. After a baseline fMRI session, subsequent sessions over different days will entail TBS, immediately followed by an MRI session to assess the effects of stimulation. TBS will involve: 1) dlPFC stimulation by active iTBS (600 pulses) alone or 2) while simultaneously performing an n-back cognitive task or 3) vertex (control) iTBS stimulation, alone.

Official TitleTheta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State
NCT04010461
Principal SponsorUniversity of Michigan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

53 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Women of child bearing age can not be pregnant or trying to become pregnant

Ability to tolerate small, enclosed spaces without anxiety

Size compatible with scanner gantry, e. g. men over 6 feet tall that weigh more than 250 lbs, men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficult fitting into the fMRI scanner properly

Ability and willingness to give informed consent to participate

Show More Criteria

6 exclusion criteria prevent from participating
History of past or current mental illness (except simple phobias)

History of closed head injury, for example, loss of consciousness > approximately 5 minutes, hospitalization, neurological sequela;

Metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition (for example; aneurysm clips, retained particles or metal workers with exposures, neurostimulators, foil-backed transdermal patches, carotid or cerebral stents, cerebral spinal fluid (CSF) shunts; magnetic dental implants, ferromagnetic ocular implants, pacemakers, and automatic implantable defibrillators).

Prescription or non-prescription, with psychotropic effects (birth control medications allowed)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
TMS (intermittent theta burst stimulation) will be applied to the dlPFC, when subjects are engaged in the n-back working memory task

Group II

Experimental
TMS (intermittent theta burst stimulation) will be applied to the dlPFC, when subjects are in a resting state

Group III

Experimental
TMS (intermittent theta burst stimulation) will be applied to the cerebral vertex, when subjects are in a resting state

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Michigan

Ann Arbor, United StatesOpen University of Michigan in Google Maps
CompletedOne Study Center
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