cTBS/fMRI Study of Hierarchical Control in the PFC

NCT ID: NCT04464473

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-23
• Study Completion Date: 2023-04-25

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 (C-O-M-I-C) and spatial sequence (Top Left-Top Right-Bottom Left-Bottom Right-Top Left) 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.

Conditions

Transcranial Magnetic Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

FPl-TMS

Transcranial magnetic stimulation to the lateral frontal pole. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold.

Group Type: EXPERIMENTAL

transcranial magnetic stimulation

Intervention Type: DEVICE

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

MFG-TMS

Transcranial magnetic stimulation to the middle frontal gyrus. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold..

Group Type: EXPERIMENTAL

transcranial magnetic stimulation

Intervention Type: DEVICE

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

S1-TMS

Transcranial magnetic stimulation to primary somatosensory cortex. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold..

Group Type: ACTIVE_COMPARATOR

transcranial magnetic stimulation

Intervention Type: DEVICE

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

Interventions

transcranial magnetic stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Derek Nee

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derek E Nee, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Florida State University Psychology Department Building

Tallahassee, Florida, United States

FSU MRI Facility

Tallahassee, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MH121509

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000532

Identifier Type: -

Identifier Source: org_study_id