- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04464473
cTBS/fMRI Study of Hierarchical Control in the PFC
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gabriella T Vill, BA
- Phone Number: 850-645-4066
- Email: vill@psy.fsu.edu
Study Locations
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-
Florida
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Tallahassee, Florida, United States, 32303
- Florida State University Psychology Department Building
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Tallahassee, Florida, United States, 32306
- FSU MRI Facility
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
- Metal anywhere in the head excluding the mouth
- 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
Arms and Interventions
Participant Group / 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 40 seconds at 80% of active motor threshold.
|
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 40 seconds at 80% of active motor threshold..
|
Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.
|
Active Comparator: 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..
|
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 |
---|---|---|
PFC-PPC effective connectivity
Time Frame: 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]
|
baseline, pre-intervention and immediately after intervention
|
PFC-PPC activation
Time Frame: 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]
|
baseline, pre-intervention and immediately after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
temporal control performance
Time Frame: baseline, pre-intervention and immediately after intervention
|
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
|
contextual control performance
Time Frame: baseline, pre-intervention and immediately after intervention
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Derek E Nee, PhD, Florida State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00000532
- R01MH121509 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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