N/A N=53 Single-blind Basic Science

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT04010461 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: Primary: 2-back Minus 1-back Blood Oxygen Level-Dependent (BOLD) Activation, Voxelwise in FPN — 0.74; 0.75; 0.58 arbitrary units — p==0.11

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: TMS (Device); n-back working memory task (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY 2-back Minus 1-back Blood Oxygen Level-Dependent (BOLD) Activation, Voxelwise in FPN	0.74; 0.75; 0.58	=0.11
PRIMARY Frontoparietal Network (FPN) Connectivity to Dorsolateral Prefrontal Cortex (dlPFC) Theta Burst Stimulation (TBS) Target	0; 10; 0	1
PRIMARY Cerebral Blood Flow (rCBF) at Stimulation Target	57.2; 57.9; 58.4	0.91
PRIMARY Accuracy to 2-back	96.7; 96.7; 96.2	0.55
SECONDARY 2-back Minus 1-back BOLD Activation, Voxelwise in Whole Brain	1139; 1532; 907	0.54
SECONDARY Measure Cerebral Blood Flow (rCBF) in FPN	52.7; 52.9; 51.9	0.8
SECONDARY Median Reaction Time (RT) in 2-back	573.2; 556.4; 572.1	0.06
SECONDARY D-prime in 2-back	3.8; 3.8; 3.7	0.41

Summary

The purpose of this study is to improve understanding of the way transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation, affects the brain. The study hypothesis that when theta burst stimulation (TBS) is applied during a controlled mental state, network changes will be facilitated, compared to stimulation when mental state is uncontrolled. This study will focus on the dorsolateral prefrontal cortex (dlPFC) and the associated frontoparietal 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. Healthy volunteers that qualify for this study will have psychological assessments and cognitive measures (due to Covid, some of these were done via teleconference), as well as functional Magnetic Resonance Imaging (fMRI) scans, completed after administration of TMS. Participants will be asked to come in for a total of five visits that include; a screening and assessment visit; a baseline functional magnetic resonance imaging (fMRI) scan, followed by TMS session; Visits 3, 4, and 5 will be the experimental TMS session, followed by fMRI scan.

Eligibility Criteria

Inclusion Criteria

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
Alcohol or drug dependence (if in remission for greater than 5 years)

Exclusion Criteria

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)
First-degree family members with a history of epilepsy
History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04010461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.