iTBS/fMRI Study of Hierarchical Control in the PFC

Sponsor
Florida State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05878080
Collaborator
National Institute of Mental Health (NIMH) (NIH)
40
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3
14
20
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: transcranial magnetic stimulation
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
iTBS/fMRI Study of Hierarchical Control in the PFC
Actual Study Start Date :
May 15, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jul 14, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: FPl-TMS

Transcranial magnetic stimulation to the lateral frontal pole. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds repeated every 10 seconds at 80% of active motor threshold.

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

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 active 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 active motor threshold.

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

Outcome Measures

Primary Outcome Measures

  1. Change in PFC-PPC effective connectivity [baseline, pre-intervention and immediately after intervention]

    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]

  2. Change in PFC-PPC activation [baseline, pre-intervention and immediately after intervention]

    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 Outcome Measures

  1. Change in temporal control speed [baseline, pre-intervention and immediately after intervention]

    behavioral performance (reaction time in milliseconds) on conditions involving temporal control in the comprehensive control task

  2. Change in temporal control accuracy [baseline, pre-intervention and immediately after intervention]

    behavioral performance (percent correct) on conditions involving temporal control in the comprehensive control task

  3. Change in contextual control speed [baseline, pre-intervention and immediately after intervention]

    behavioral performance (reaction time in milliseconds) on conditions involving contextual control in the comprehensive control task

  4. Change in contextual control accuracy [baseline, pre-intervention and immediately after intervention]

    behavioral performance (reaction time in milliseconds) on conditions involving contextual control in the comprehensive control task

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Florida State University Psychology Department Building Tallahassee Florida United States 32303
2 FSU MRI Facility Tallahassee Florida United States 32306

Sponsors and Collaborators

  • Florida State University
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Derek E Nee, PhD, Florida State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Derek Nee, Associate Professor, Florida State University
ClinicalTrials.gov Identifier:
NCT05878080
Other Study ID Numbers:
  • STUDY00000533
  • R01MH121509
First Posted:
May 26, 2023
Last Update Posted:
May 26, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes

Study Results

No Results Posted as of May 26, 2023