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iTBS/fMRI Study of Hierarchical Control in the PFC

iTBS/fMRI Study of Hierarchical Control in the PFC

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05878080
Enrollment
54
Registered
2023-05-26
Start date
2023-05-15
Completion date
2024-12-02
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transcranial Magnetic Stimulation

Brief summary

The objective of this study is to examine the effect of transcranial magnetic stimulation (TMS) on the prefrontal cortex and posterior parietal cortex.

Detailed description

The Comprehensive Control Task (CCT) was designed to examine hierarchical control in a single, well-controlled factorial task. On each trial, participants view a letter surrounded by a colored shape at a particular screen location. Color cues the relevant feature, letter or location, for a block of trials. The first trial of a block requires a decision of whether the stimulus is the first position of a circular sequence (sequence start). Subsequent trials require a decision of whether the viewed stimulus follows the previous stimulus in a circular sequence (sequence 1-back). The letter sequence (T-A-B-L-E-T) and spatial sequence (Top-Bottom Right-Left-Right-Bottom Left-Top) are difficulty-matched. Shape cues the task to perform. Squares indicate the standard baseline task, and each block begins and ends with baseline trials. Different shapes indicate sub-tasks. In Switching blocks, shape-switches (e.g. from square to circle or circle to square) cue the sequence start task. Shape-repeats cue the sequence 1-back task. In Planning blocks, triangle shapes indicate that the stimulus can be ignored (automatic "no" response). All the while, the last square-shaped stimulus must be retained as a reference for the next square-shaped stimulus. Finally, in Dual blocks, diamond shapes indicate switching (sequence start) and also planning. The reversion back to square shapes requires sequence matching to the distal, previous square. The design is factorial with stimulus-domain x contextual control x temporal control orthogonally manipulated. Full details of the CCT have been previous described in Nee & D'Esposito, 2016; 2017. The focus in this study will be comparison of FPl-TMS, MFG-TMS, and S1-TMS in an interleaved fMRI-TMS-fMRI design. The logic is to test the apical status of the FPl/MFG through the extent to which TMS impacts other PFC areas and behavior. Each experiment will begin with 1 session of the CCT with fMRI to localize PFC targets. Each participant will then perform 3 counter-balanced sessions wherein a different site will be targeted by TMS followed immediately by fMRI on the CCT.

Interventions

DEVICEtranscranial magnetic stimulation

Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.

Sponsors

Florida State University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Between the ages of 18 and 30 * Right-handed * Native English speaker or fluent by the age of 6

Exclusion criteria

* History of psychiatric disorders * History of neurological disorders * Receiving medications for psychiatric or neurological disorders * Familial history of epilepsy * Taking any drugs or medications that are pro-epileptic * Metal anywhere in the head excluding the mouth * Tinnitus * Women who are pregnant

Design outcomes

Primary

MeasureTime frameDescription
PFC-PPC Effective Connectivitybaseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)effective connectivity among areas of the prefrontal and posterior parietal cortex in the blood oxygenation level dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) \[note, this measure has no units, but effective connectivity is a rate measure, so is expressed in Hertz\]
PFC-PPC Activationbaseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)blood oxygenation level dependent (BOLD) signal in areas of the prefrontal and posterior parietal cortex assessed with functional magnetic resonance imaging (fMRI) \[note, this measure has no units\]

Secondary

MeasureTime frameDescription
Temporal Control Performance (Error Rate)baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)behavioral performance (error rate) on conditions involving temporal control in the comprehensive control task
Contextual Control Performance (Error Rate)baseline, pre-intervention and immediately after intervention (t minutes to 1 hour post-TMS)behavioral performance (error rate) on conditions involving contextual control in the comprehensive control task
Temporal x Contextual Control Performance (Error Rate)baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)behavioral performance (error rate) of the interaction of temporal and contextual control in the comprehensive control task
Temporal Control Performance (Reaction Time)baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)behavioral performance (reaction time in milliseconds) on conditions involving temporal control in the comprehensive control task
Contextual Control Performance (Reaction Time)baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)behavioral performance (reaction time in milliseconds) on conditions involving contextual control in the comprehensive control task
Temporal x Contextual Control Performance (Reaction Time)baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)behavioral performance (reaction time in milliseconds) on the interaction between temporal control and contextual control in the comprehensive control task

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDerek E Nee, PhD

Florida State University

Participant flow

Pre-assignment details

After enrollment, participants complete 1) a baseline functional MRI scan to determine targets for transcranial magnetic stimulation, and 2) motor thresholding to determine intensity of transcranial magnetic stimulation. Participants are not assigned to arms if they cannot perform the task inside the MRI scanner (e.g. due to claustrophobia) or if they cannot tolerate transcranial magnetic stimulation.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
39 Participants
Age, Continuous19.8 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
7 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
4 Participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 370 / 340 / 35
other
Total, other adverse events
4 / 371 / 340 / 35
serious
Total, serious adverse events
0 / 370 / 340 / 35

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026