iTBS/fMRI Study of Apex Control

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

Study Overview

• Status: Recruiting
• Conditions: Transcranial Magnetic Stimulation
• Intervention / Treatment: Device: transcranial magnetic stimulation

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 previously described in published work.

The focus in this study will be comparison of MFG-TMS, IPL-TMS, and S1-TMS in an interleaved fMRI-TMS-fMRI design. The logic is to test the apical status of the MFG/IPL through the extent to which TMS impacts other PFC/PPC areas and behavior.

Each experiment will begin with 1 session of the CCT with fMRI to localize TMS 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Derek Nee, PhD; Phone Number: 850-644-1963; Email: dnee@fsu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Recruiting
      • FSU MRI Facility
      • Contact: Alecia Lapointe, MA; Phone Number: 850-644-1889; Email: alecia.lapointe@med.fsu.edu
    • Tallahassee, Florida, United States, 32306
      • Recruiting
      • Florida State University Psychology Department Building
      • Contact: Derek Nee, PhD; Phone Number: 850-644-1963; Email: dnee@fsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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
• Tinnitus
• Women who are pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MFG-TMS; Transcranial magnetic stimulation to the middle frontal gyrus. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds repeated every 10 seconds at 80% of resting motor threshold.	Device: transcranial magnetic stimulation; Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.
Experimental: IPL-TMS; Transcranial magnetic stimulation to the inferior parietal lobule. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds repeated every 10 seconds at 80% of resting motor threshold.	Device: transcranial magnetic stimulation; Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.
Active Comparator: S1-TMS; Transcranial magnetic stimulation to the primary somatosensory cortex. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds repeated every 10 seconds at 80% of resting motor threshold.	Device: transcranial magnetic stimulation; Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PFC-PPC effective connectivity	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]	baseline, pre-intervention and immediately after intervention
Change in PFC-PPC activation	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]	baseline, pre-intervention and immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in temporal control speed	behavioral performance (reaction time in milliseconds) on conditions involving temporal control in the comprehensive control task	baseline, pre-intervention and immediately after intervention
Change in temporal control accuracy	behavioral performance (percent correct) on conditions involving temporal control in the comprehensive control task	baseline, pre-intervention and immediately after intervention
Change in contextual control speed	behavioral performance (reaction time in milliseconds) on conditions involving contextual control in the comprehensive control task	baseline, pre-intervention and immediately after intervention
Change in contextual control accuracy	behavioral performance (reaction time in milliseconds) on conditions involving contextual control in the comprehensive control task	baseline, pre-intervention and immediately after intervention

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Derek Nee, PhD, Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: 0000033961; R01MH121509 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Behavioral and imaging data will be shared
• IPD Sharing Time Frame: Within a year following publication of findings
• IPD Sharing Access Criteria: Behavioral and imaging data will be accessible from NIMH Data Archive
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes