Transcranial Magnetic StimulationNCT05878080
iTBS/fMRI Study of Hierarchical Control in the PFC
A study testing transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation, run by Florida State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Magnetic Stimulation
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2023to 2 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 30
- Right-handed
- Native English speaker or fluent by the age of 6
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida State University Psychology Department Building
Tallahassee, Florida, 32303
FSU MRI Facility
Tallahassee, Florida, 32306
About this study
The objective of this study is to examine the effect of transcranial magnetic stimulation (TMS) on the prefrontal cortex and posterior parietal cortex.
Read the 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.
- Conditions
- Transcranial Magnetic Stimulation
- Being tested
- transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.
| Study group | Role | What they receive |
|---|---|---|
| FPl-TMS | Experimental | 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. Receives: Device: transcranial magnetic stimulation |
| MFG-TMS | Experimental | 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. Receives: Device: transcranial magnetic stimulation |
| S1-TMS | Active comparator | 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. Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, but effective connectivity is a rate measure, so is expressed in Hertz]
Measured: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
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]
Measured: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
Secondary outcomes (6)
Temporal Control Performance (Error Rate)
behavioral performance (error rate) on conditions involving temporal control in the comprehensive control task
Measured: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
Contextual Control Performance (Error Rate)
behavioral performance (error rate) on conditions involving contextual control in the comprehensive control task
Measured: baseline, pre-intervention and immediately after intervention (t minutes to 1 hour post-TMS)
Temporal x Contextual Control Performance (Error Rate)
behavioral performance (error rate) of the interaction of temporal and contextual control in the comprehensive control task
Measured: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
Temporal Control Performance (Reaction Time)
behavioral performance (reaction time in milliseconds) on conditions involving temporal control in the comprehensive control task
Measured: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
Contextual Control Performance (Reaction Time)
behavioral performance (reaction time in milliseconds) on conditions involving contextual control in the comprehensive control task
Measured: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
Temporal x Contextual Control Performance (Reaction Time)
behavioral performance (reaction time in milliseconds) on the interaction between temporal control and contextual control in the comprehensive control task
Measured: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start15 May 2023
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Derek Nee, Florida State University
- Investigators
- Derek E Nee, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878080
- Sponsor's protocol ID
- STUDY00000533
- Other IDs
- R01MH121509
- Status last verified
- Feb 2026
- First submitted
- 18 May 2023
- Last updated
- 25 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Behavioral and imaging data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iTBS/fMRI Study of Hierarchical Control in the PFC
- ClinicalTrials.gov ID
- NCT05878080
- Acronym / sponsor ID
- STUDY00000533
- Conditions
- Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Posted 25 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FPl-TMS | Experimental | Device: transcranial magnetic stimulationTranscranial 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. |
| MFG-TMS | Experimental | Device: transcranial magnetic stimulationTranscranial 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. |
| S1-TMS | Active comparator | Device: transcranial magnetic stimulationTranscranial 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 30
- Right-handed
- Native English speaker or fluent by the age of 6
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial magnetic stimulationTranscranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance. | Device | FPl-TMS, MFG-TMS, S1-TMS |
Primary outcome
PFC-PPC Effective Connectivity
Time frame: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
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, but effective connectivity is a rate measure, so is expressed in Hertz]
PFC-PPC Activation
Time frame: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
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]
6 secondary outcomes
Temporal Control Performance (Error Rate)
Time frame: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
Contextual Control Performance (Error Rate)
Time frame: baseline, pre-intervention and immediately after intervention (t minutes to 1 hour post-TMS)
Temporal x Contextual Control Performance (Error Rate)
Time frame: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
Temporal Control Performance (Reaction Time)
Time frame: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
Contextual Control Performance (Reaction Time)
Time frame: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
Temporal x Contextual Control Performance (Reaction Time)
Time frame: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Behavioral and imaging data will be shared
Related trials for Transcranial Magnetic Stimulation
Recruiting
Adaptive Recruitment Curve Analysis Using Bayesian Modeling
Modeling of Recruitment Curves
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Not yet recruiting
Motor Imagery and Turning Practice to Improve Mobility: Pilot Trial
Mobility Impairment, Community Dwelling Older Adults
Recruiting
Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia
Dystonia Disorder
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek E Nee, PhD principal investigator
Florida State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation, run by Florida State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFC-PPC Effective Connectivity (time frame: baseline, pre-intervention and immediately after intervention (5 minutes to 1 hour post-TMS)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.