cTBS/fMRI Study of Hierarchical Control in the PFC

Transcranial Magnetic Stimulation Clinical Trial

Official title:

cTBS/fMRI Study of Hierarchical Control in the PFC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464473
• Other study ID #: STUDY00000532
• Secondary ID: R01MH121509
• Status: Completed
• Phase: N/A
• Start date: July 23, 2021
• Est. completion date: April 25, 2023

Study information

• Verified date: October 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 25, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Transcranial Magnetic Stimulation

Intervention

Device:
• transcranial magnetic stimulation
Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.

Locations

Country	Name	City	State
United States	Florida State University Psychology Department Building	Tallahassee	Florida
United States	FSU MRI Facility	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	temporal control performance	behavioral performance (reaction time in milliseconds, and percent correct) on conditions involving temporal control in the comprehensive control task	baseline, pre-intervention and immediately after intervention
Secondary	contextual control performance	behavioral performance (reaction time in milliseconds, and percent correct) on conditions involving contextual control in the comprehensive control task	baseline, pre-intervention and immediately after intervention