Rhythmic Transcranial Magnetic Stimulation (rTMS) Effect on Hierarchical Cognitive ControlNCT06734377
Causal Role of Delta and Theta Oscillations in Hierarchical Cognitive Control
A study testing Delta TMS, Theta TMS and Arrhythmic TMS in people with Rhythmic Transcranial Magnetic Stimulation (rTMS) Effect on Hierarchical Cognitive Control, run by Florida State University at 1 site in United States.
Trial summary
The purpose of this clinical trial is to evaluate the effect of rhythmic transcranial magnetic stimulation (TMS) delivered at delta (2.2 Hz) or theta (6.5 Hz) frequency on cognitive control. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhythmic Transcranial Magnetic Stimulation (rTMS) Effect on Hierarchical Cognitive Control
- What is being tested?
- Delta TMS, Theta TMS and Arrhythmic TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2025to 17 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be between the ages of 18 and 35.
- Must be able to provide informed consent.
- Must have normal or corrected-to-normal vision.
- Participants must be right-handed.
- Willingness to comply with all study procedures and availability for the study duration.
- Proficiency in speaking and understanding English.
Who cannot join
- Must not be color-blind
- Current treatment for ADHD/ADD.
- History of neurological disorders, including but not limited to the following specified conditions
- Epilepsy or seizures (excluding childhood febrile seizures).
- Dementia, Parkinson's disease, multiple sclerosis, cerebral aneurysm, or brain tumors.
- History of stroke or traumatic brain injury.
Show all 11Show fewer
- Medical conditions or treatments that could interfere with study participation (e.g., unstable cardiac disease, HIV/AIDS, malignancy, or renal impairment).
- Prior brain surgery or presence of brain devices/implants (e.g., cochlear implants or aneurysm clips).
- Females who are pregnant or breastfeeding.
- Use of specific medications, including but not limited to ADHD medications or benzodiazepines, which may interfere with EEG measurements or task performance
- Any condition that, in the opinion of the investigator, increases risk or hinders full compliance with the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University Psychology Dept Bldg A411
Tallahassee, Florida, 32304
About this study
The purpose of this clinical trial is to evaluate the effect of rhythmic transcranial magnetic stimulation (TMS) delivered at delta (2.2 Hz) or theta (6.5 Hz) frequency on cognitive control.
This study aims to explore how targeted stimulation at delta and theta frequencies modulates brain activity to enhance cognitive performance in healthy populations.
Read the detailed description
Neural oscillations are proposed to be a mechanism of coordinating information processing across distributed regions of cortex. Different neural oscillations may correspond to different underlying neural computations. Noninvasive brain stimulation allows experimenters to modulate specific neural oscillations by targeting particular frequency bands. Rhythmic transcranial magnetic stimulation (TMS) has been previously demonstrated to entrain neural oscillations at the frequency of stimulation.
Previous evidence suggests that cognitive control task paradigms elicit distinct activity in both Delta band (2-3 Hz) and Theta band (4-7 Hz). This task is designed to examine hierarchical cognitive control and includes two subtasks. In the Response Task, participants see a colored fixation cross and must make a button press with a specific finger. The stimulus to response mapping is memorized ahead of time. The number of stimulus to response rules is manipulated as four (low set-size) or eight (high set-size). In the Dimension Task, participants see two objects and must judge whether they are the same or different depending on one of two features. One feature is the shape of the object as either tall or wide. The other feature is the complexity of the objects as either being simple and smooth or complex and multifaceted. In this task, delta oscillations (2-3 Hz) are associated with rule abstraction, engaging the mid-dorsolateral prefrontal cortex (mid-dlPFC), while theta oscillations (4-7 Hz) are linked to stimulus-action associations and working memory load, with increased theta activity observed in the dorsal premotor area (PMd) under high set-size conditions.
For the current study, the investigators propose to deliver rhythmic trains of TMS in either delta frequency, theta frequency, or an arrhythmic control to modulate neural processing during a cognitive control task. By collecting simultaneous EEG with TMS, the investigators will be able to measure the entrained oscillations from rhythmic TMS. By applying delta frequency, theta frequency, and arrhythmic TMS during the performance of the task at each location, the investigators will be able to examine the causal relationship of delta oscillations at mid-dlPFC in rule abstraction and theta oscillations at PMd in stimulus-action associations. The stimulation is designed to enhance task performance by amplifying the neural activity patterns observed under these conditions.
- Conditions
- Rhythmic Transcranial Magnetic Stimulation (rTMS) Effect on Hierarchical Cognitive Control
- Being tested
- Delta TMS, Theta TMS, Arrhythmic TMS
- Keywords
- Rhythmic Transcranial Magnetic Stimulation, Hierarchical Cogntive Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta TMSDevice
Also called MagPro X100 or R30 system
TMS will be administered at the frequency of delta oscillation (2.2Hz)
Theta TMSDevice
Also called MagPro X100 or R30 system
TMS will be administered at the frequency of theta oscillation (6.5Hz)
Arrhythmic TMSDevice
TMS will be administered arrhythmically. In this intervention, the inter-pulse intervals are randomized between delta and theta durations for each trial, ensuring the same total number of pulses but without rhythmic consistency
| Study group | Role | What they receive |
|---|---|---|
| TMS to Mid-dlPFC followed by TMS to PMd | Experimental | Participants would receive TMS while performing a cognitive control task. In their first stimulation session, the TMS coil will be placed over mid-dlPFC region on the scalp. In their second session, the TMS coil will be placed over the PMd region on the scalp. During every session, participants receive Delta TMS (2.2 Hz), Theta TMS (6.5 Hz), and Arrhythmic TMS. Receives: Device: Delta TMS; Device: Theta TMS; Device: Arrhythmic TMS |
| TMS to PMd followed by TMS to Mid-dlPFC | Experimental | Participants would receive TMS while performing a cognitive control task. In their first stimulation session, the TMS coil will be placed over PMd region on the scalp. In their second session, the TMS coil will be placed over the mid-dlPFC region on the scalp. During every session, participants receive Delta TMS (2.2 Hz), Theta TMS (6.5 Hz), and Arrhythmic TMS. Receives: Device: Delta TMS; Device: Theta TMS; Device: Arrhythmic TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Accuracy
The Accuracy, reflecting the participants' ability to correctly follow task rules and make accurate judgments based on the given stimulus, is calculated as the percentage of correct responses across trials. The value range is 0% (no correct responses) to 100% (all responses correct), with a larger number denoting more correct responses.
Measured: Baseline (week 1); Session 1 (week 2); Session 2 (week 3)
Secondary outcomes (3)
Change in Response Time
The Response Time (RT), reflects the time taken by participants to respond to stimuli during the task. The value range is 0 seconds to 2 seconds, with a smaller number denoting faster responses.
Measured: Baseline (week 1); Session 1 (week 2); Session 2 (week 3)
Change in Amplitude of Neural Oscillations in mid-dlPFC
The electrical activity of the brain is recorded during the performance of the task and brain stimulation. The investigators will perform Morlet wavelet convolution on the recorded electrical signal to calculate the amplitude of neural oscillations in the frequency bands: Delta (2-3 Hz) and Theta (4-7 Hz). The amplitude of neural oscillations is reported in the region that is being stimulated. The change in amplitude is normalized for each participant as the percent change from the amplitude during the baseline compared to the stimulation session (Session 1 or Session 2).
Measured: Baseline (week 1); Session 1 (week 2); Session 2 (week 3)
Change in Amplitude of Neural Oscillations in PMd
The electrical activity of the brain is recorded during the performance of the task and brain stimulation. The investigators will perform Morlet wavelet convolution on the recorded electrical signal to calculate the amplitude of neural oscillations in the frequency bands: Delta (2-3 Hz) and Theta (4-7 Hz). The amplitude of neural oscillations is reported in the region that is being stimulated. The change in amplitude is normalized for each participant as the percent change from the amplitude during the baseline compared to the stimulation session (Session 1 or Session 2).
Measured: Baseline (week 1); Session 1 (week 2); Session 2 (week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start20 Jan 2025
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhythmic Transcranial Magnetic Stimulation (rTMS) Effect on Hierarchical Cognitive ControlStudies 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
- Model description
- Each participant receives all three types of stimulations (delta, theta, arrhythmic) in both brain regions, with the order of stimulation randomized for each session. Across the 12 task blocks in each session with the stimulation, the type of stimulation is interleaved, ensuring that all conditions are represented in a balanced manner. The number of trials for each stimulation condition is counterbalanced within and across blocks to provide equal exposure to each type.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Riddle, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734377
- Sponsor's protocol ID
- 00005546
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
PubMed 33243615
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causal Role of Delta and Theta Oscillations in Hierarchical Cognitive Control
- ClinicalTrials.gov ID
- NCT06734377
- Acronym / sponsor ID
- 00005546
- Conditions
- Rhythmic Transcranial Magnetic Stimulation (rTMS) Effect on Hierarchical Cognitive Control
- Keywords
- Rhythmic Transcranial Magnetic Stimulation, Hierarchical Cogntive Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to evaluate the effect of rhythmic transcranial magnetic stimulation (TMS) delivered at delta (2.2 Hz) or theta (6.5 Hz) frequency on cognitive control.
This study aims to explore how targeted stimulation at delta and theta frequencies modulates brain activity to enhance cognitive performance in healthy populations.
Detailed description
Neural oscillations are proposed to be a mechanism of coordinating information processing across distributed regions of cortex. Different neural oscillations may correspond to different underlying neural computations. Noninvasive brain stimulation allows experimenters to modulate specific neural oscillations by targeting particular frequency bands. Rhythmic transcranial magnetic stimulation (TMS) has been previously demonstrated to entrain neural oscillations at the frequency of stimulation.
Previous evidence suggests that cognitive control task paradigms elicit distinct activity in both Delta band (2-3 Hz) and Theta band (4-7 Hz). This task is designed to examine hierarchical cognitive control and includes two subtasks. In the Response Task, participants see a colored fixation cross and must make a button press with a specific finger. The stimulus to response mapping is memorized ahead of time. The number of stimulus to response rules is manipulated as four (low set-size) or eight (high set-size). In the Dimension Task, participants see two objects and must judge whether they are the same or different depending on one of two features. One feature is the shape of the object as either tall or wide. The other feature is the complexity of the objects as either being simple and smooth or complex and multifaceted. In this task, delta oscillations (2-3 Hz) are associated with rule abstraction, engaging the mid-dorsolateral prefrontal cortex (mid-dlPFC), while theta oscillations (4-7 Hz) are linked to stimulus-action associations and working memory load, with increased theta activity observed in the dorsal premotor area (PMd) under high set-size conditions.
For the current study, the investigators propose to deliver rhythmic trains of TMS in either delta frequency, theta frequency, or an arrhythmic control to modulate neural processing during a cognitive control task. By collecting simultaneous EEG with TMS, the investigators will be able to measure the entrained oscillations from rhythmic TMS. By applying delta frequency, theta frequency, and arrhythmic TMS during the performance of the task at each location, the investigators will be able to examine the causal relationship of delta oscillations at mid-dlPFC in rule abstraction and theta oscillations at PMd in stimulus-action associations. The stimulation is designed to enhance task performance by amplifying the neural activity patterns observed under these conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant receives all three types of stimulations (delta, theta, arrhythmic) in both brain regions, with the order of stimulation randomized for each session. Across the 12 task blocks in each session with the stimulation, the type of stimulation is interleaved, ensuring that all conditions are represented in a balanced manner. The number of trials for each stimulation condition is counterbalanced within and across blocks to provide equal exposure to each type.
| Arm | Type | Receives |
|---|---|---|
| TMS to Mid-dlPFC followed by TMS to PMd | Experimental | Device: Delta TMS, Device: Theta TMS, Device: Arrhythmic TMSParticipants would receive TMS while performing a cognitive control task. In their first stimulation session, the TMS coil will be placed over mid-dlPFC region on the scalp. In their second session, the TMS coil will be placed over the PMd region on the scalp. During every session, participants receive Delta TMS (2.2 Hz), Theta TMS (6.5 Hz), and Arrhythmic TMS. |
| TMS to PMd followed by TMS to Mid-dlPFC | Experimental | Device: Delta TMS, Device: Theta TMS, Device: Arrhythmic TMSParticipants would receive TMS while performing a cognitive control task. In their first stimulation session, the TMS coil will be placed over PMd region on the scalp. In their second session, the TMS coil will be placed over the mid-dlPFC region on the scalp. During every session, participants receive Delta TMS (2.2 Hz), Theta TMS (6.5 Hz), and Arrhythmic TMS. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants must be between the ages of 18 and 35.
- Must be able to provide informed consent.
- Must have normal or corrected-to-normal vision.
- Participants must be right-handed.
- Willingness to comply with all study procedures and availability for the study duration.
Key exclusion criteria (11 listed)
- Must not be color-blind
- Current treatment for ADHD/ADD.
- History of neurological disorders, including but not limited to the following specified conditions
- Epilepsy or seizures (excluding childhood febrile seizures).
- Dementia, Parkinson's disease, multiple sclerosis, cerebral aneurysm, or brain tumors.
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 |
|---|---|---|
| Delta TMSAlso: MagPro X100 or R30 systemTMS will be administered at the frequency of delta oscillation (2.2Hz) | Device | TMS to Mid-dlPFC followed by TMS to PMd, TMS to PMd followed by TMS to Mid-dlPFC |
| Theta TMSAlso: MagPro X100 or R30 systemTMS will be administered at the frequency of theta oscillation (6.5Hz) | Device | TMS to Mid-dlPFC followed by TMS to PMd, TMS to PMd followed by TMS to Mid-dlPFC |
| Arrhythmic TMSTMS will be administered arrhythmically. In this intervention, the inter-pulse intervals are randomized between delta and theta durations for each trial, ensuring the same total number of pulses but without rhythmic consistency | Device | TMS to Mid-dlPFC followed by TMS to PMd, TMS to PMd followed by TMS to Mid-dlPFC |
Primary outcome
Change in Accuracy
Time frame: Baseline (week 1); Session 1 (week 2); Session 2 (week 3)
The Accuracy, reflecting the participants' ability to correctly follow task rules and make accurate judgments based on the given stimulus, is calculated as the percentage of correct responses across trials. The value range is 0% (no correct responses) to 100% (all responses correct), with a larger number denoting more correct responses.
3 secondary outcomes
Change in Response Time
Time frame: Baseline (week 1); Session 1 (week 2); Session 2 (week 3)
Change in Amplitude of Neural Oscillations in mid-dlPFC
Time frame: Baseline (week 1); Session 1 (week 2); Session 2 (week 3)
Change in Amplitude of Neural Oscillations in PMd
Time frame: Baseline (week 1); Session 1 (week 2); Session 2 (week 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Results publication: PubMed 33243615Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delta TMS, Theta TMS and Arrhythmic TMS in people with Rhythmic Transcranial Magnetic Stimulation (rTMS) Effect on Hierarchical Cognitive Control, run by Florida State University at 1 site 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 6 inclusion and 11 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Accuracy (time frame: Baseline (week 1); Session 1 (week 2); Session 2 (week 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06734377, which also lists 1 linked publication.
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 10 Mar 2026.