TMS for Cognitive Control

Overseen By Wu Li, B.A.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: ADHD medications, Benzodiazepines

Disqualifiers: Neurological disorders, Stroke, Brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how rhythmic brain stimulation can improve cognitive control, the brain's ability to manage tasks and focus. The researchers use transcranial magnetic stimulation (TMS), a non-invasive method that targets specific brain areas with magnetic pulses at different frequencies. Participants will receive TMS, including arrhythmic, delta, and theta TMS, at various scalp locations while performing tasks that require concentration. The trial seeks right-handed individuals who are fluent in English, have normal or corrected vision, and are not currently receiving treatment for conditions like ADHD or epilepsy. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in cognitive enhancement.

Will I have to stop taking my current medications?

The trial requires that you do not use certain medications, like ADHD medications or benzodiazepines, as they may interfere with the study. If you are on these medications, you may need to stop taking them to participate.

What prior data suggests that this TMS technique is safe for cognitive control studies?

Earlier studies found TMS (transcranial magnetic stimulation) to be safe for most people, with serious issues being rare. Research on Delta TMS shows it is generally well-tolerated, with few serious side effects. Studies on Theta TMS suggest it is safe and rarely causes serious problems, but like any treatment, it should be used carefully. Arrhythmic TMS carries a low risk of serious side effects, with most being mild and manageable, such as headaches or scalp discomfort.

This trial is not in a phase that provides safety evidence from earlier human studies. However, TMS has been used safely in other situations, suggesting it may be safe here too. Always discuss any concerns or questions with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TMS for Cognitive Control trial because it explores new ways to enhance cognitive control using Transcranial Magnetic Stimulation (TMS). Unlike traditional methods that might involve medication or behavioral therapy, this trial investigates the impact of TMS delivered to specific brain areas during cognitive tasks. The study uniquely combines different TMS frequencies—Delta, Theta, and Arrhythmic—targeting the mid-dlPFC and PMd regions, potentially offering a non-invasive and rapid approach to improving cognitive functions. This method could lead to more personalized and immediate treatment options for cognitive impairments compared to current standards.

What evidence suggests that this trial's treatments could be effective for enhancing cognitive control?

This trial will explore the effects of transcranial magnetic stimulation (TMS) on cognitive control. Participants will receive different types of TMS, including Delta TMS (2.2 Hz), Theta TMS (6.5 Hz), and Arrhythmic TMS, during cognitive control tasks. Research has shown that TMS can affect brain wave patterns, potentially improving thinking skills. Studies indicate that using TMS at specific frequencies, like delta and theta, can change brain activity and enhance focus and decision-making. Delta TMS is associated with reducing certain brain waves, while theta TMS may increase others. These changes can help the brain manage tasks better and adapt to new information. Overall, TMS's ability to adjust brain activity makes it a promising tool for boosting cognitive performance. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in participating in a study to understand how brain stimulation affects thinking skills. Specific eligibility details are not provided, so it's best to contact the research team for more information on who can join.

Inclusion Criteria

Must be able to provide informed consent

Participants must be right-handed

Proficiency in speaking and understanding English

Exclusion Criteria

I am not taking ADHD medications or benzodiazepines that could affect EEG tests.

I am not pregnant or breastfeeding.

Must not be color-blind

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline

Baseline measurements of accuracy and response time are taken before TMS sessions

1 week

1 visit (in-person)

Treatment

Participants receive rhythmic TMS at delta and theta frequencies during cognitive control tasks

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in accuracy and response time after TMS sessions

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Arrhythmic TMS
• Delta TMS
• Theta TMS

Trial Overview The trial tests how rhythmic brain stimulation at different frequencies (delta at 2.2 Hz and theta at 6.5 Hz) influences cognitive control compared to irregular rhythm TMS, using a device that generates magnetic fields over the head.

How Is the Trial Designed?

Group I: TMS to PMd followed by TMS to Mid-dlPFC Experimental Treatment 3 Interventions

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.

Group II: TMS to Mid-dlPFC followed by TMS to PMd Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Published Research Related to This Trial

Transcranial magnetic stimulation (TMS) has a very low seizure risk, with only 0.08 seizures reported per 1,000 sessions, and less than 0.02 seizures per 1,000 sessions when guidelines are followed for individuals without known risk factors.

The study found that exceeding safety guidelines increases the risk of seizures, and seizures are more likely to occur during the first few TMS sessions, suggesting that TMS is generally safe when administered properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. Lerner, AJ., Wassermann, EM., Tamir, DI.[2021]

This study will investigate how applying intermittent theta burst stimulation (iTBS) to the dorsolateral prefrontal cortex (dlPFC) during a controlled cognitive task affects brain network changes compared to stimulation without a task, involving 40 healthy subjects over three days.

The research aims to demonstrate that controlling mental state during TMS can enhance its therapeutic effects, potentially leading to improved treatments for neuropsychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theta Burst Transcranial Magnetic Stimulation of Fronto-Parietal Networks: Modulation by Mental State. Taylor, SF., Lee, TG., Jonides, J., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) at alpha (10 Hz) and theta (6 Hz) frequencies can enhance functional connectivity in brain networks associated with attention, specifically the dorsal attention network (DAN) and default mode network (DMN).

Participants receiving alpha frequency rTMS showed significant improvements in performance on a rapid visual information processing task, indicating that this type of stimulation can effectively enhance sustained attention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alpha frequency rTMS modulates theta lagged nonlinear connectivity in dorsal attention network. Kazemi, R., Rostami, R., Dehghan, S., et al.[2021]

Transcranial magnetic stimulation (TMS) can have long-lasting effects, especially with certain protocols like the 20-Hz multi-day TMS, which raises concerns about potential harm if effects persist beyond the lab setting.

To ensure TMS remains a safe and effective tool in cognitive neuroscience, guidelines are proposed, including verifying that effects dissipate before participants leave, conducting thorough cognitive assessments, and ensuring robust participant numbers for reliable results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TMS must not harm participants: guidelines for evaluating TMS protocol safety. Slotnick, SD.[2023]

Transcranial magnetic stimulation (TMS) has a strong safety record, with seizures being an extremely rare adverse effect, particularly in patients receiving repetitive TMS (rTMS) under certain conditions.

The updated guidelines provide comprehensive safety recommendations for TMS applications, including risk assessments for new stimulation paradigms and precautions for use in patients with implanted devices or in neuroimaging settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Rossi, S., Hallett, M., Rossini, PM., et al.[2022]

Transcranial magnetic stimulation (TMS), particularly repetitive TMS (rTMS) using theta-burst stimulation (TBS), is a promising non-invasive technique for enhancing brain plasticity and has potential therapeutic applications for various neurological and psychiatric disorders.

The review highlights the importance of TMS-EEG techniques and neuronavigation in improving the precision of TMS, as well as the variability in TBS effects influenced by factors like age and genetics, which could inform personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the mechanisms of brain plasticity by transcranial magnetic stimulation. Jannati, A., Oberman, LM., Rotenberg, A., et al.[2023]

Transcranial magnetic stimulation (TMS) can effectively study neural plasticity through various methods, including mapping cortical output and identifying mechanisms of neuroplasticity, as demonstrated in procedural learning tasks like the serial reaction time task.

TMS can enhance neuroimaging techniques and modulate cortical function to influence behavior, showcasing its potential in cognitive neuroscience research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation and neuroplasticity. Pascual-Leone, A., Tarazona, F., Keenan, J., et al.[2019]

Transcranial magnetic stimulation (TMS) is generally safe and does not cause persistent changes in cognitive function or EEG, although transient effects may occur during treatment.

While TMS does not typically induce seizures, there is a potential risk for individuals with heightened susceptibility, indicating that further research is needed to fully understand any unwanted effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of transcranial magnetic stimulation reconsidered: evidence regarding cognitive and other cerebral effects. Bridgers, SL.[2007]

Transcranial magnetic stimulation (TMS) using continuous theta burst stimulation (cTBS) can effectively reduce functional connectivity (FC) between the left dorsolateral prefrontal cortex and regions of the default mode network in healthy individuals, indicating its potential to modulate brain connectivity.

The study utilized resting state fMRI to measure FC before and after real and sham stimulation, demonstrating that the inhibitory effects of cTBS can lead to significant changes in brain connectivity, which may have implications for treating neuropsychological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theta-burst transcranial magnetic stimulation induced functional connectivity changes between dorsolateral prefrontal cortex and default-mode-network. Shang, Y., Chang, D., Zhang, J., et al.[2021]

Transcranial magnetic stimulation (TMS) is increasingly used in cognitive neuroscience to explore brain functions, with various protocols available, including single pulse and repetitive TMS, which help researchers investigate complex cognitive processes.

Recent advancements in TMS techniques, such as combining TMS with neuroimaging and state-dependent TMS, enhance the understanding of brain interactions and improve the safety and efficacy of TMS applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of transcranial magnetic stimulation in cognitive neuroscience: a new synthesis of methodological issues. Sandrini, M., Umiltà, C., Rusconi, E.[2010]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10805393/

rTMS reduces delta and increases theta oscillations in ... Cognitive outcomes of TMS treatment in bipolar depression: safety data from a randomized controlled trial. J Affect Disord. 2018;235:20‐26 ...

2. trialx.com trialx.com/clinical-trials/listings/309020/causal-role-of-delta-and-theta-oscillations-in-hierarchical-cognitive-control/

Causal Role of Delta and Theta Oscillations in Hierarchical ... The purpose of this clinical trial is to evaluate the effect of rhythmic transcranial magnetic stimulation (TMS) delivered at delta (2.2 Hz) or ...

3. withpower.com withpower.com/trial/phase-rhythmic-transcranial-magnetic-stimulation-rtms-effect-on-hierarchical-cognitive-control-2025-53fbd

TMS for Cognitive Control 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) ...

4. cre.fsu.edu cre.fsu.edu/system/files/webform/research_symposium_webform/18576/BrownM_poster.pdf

Investigating the neural basis of cognitive control using ... Cognitive control is the capacity to flexibly adapt behavior and execute rapid decision-making based on internal goals and environmental demands1.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032725016362

Predictive and mechanistic biomarkers of treatment ... Additionally, little is known about how TMS can change the underlying neurophysiology of psychiatric and neurocognitive disorders to improve ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9094636/

Safety and recommendations for TMS use in healthy subjects ... We provide an update on TMS-induced seizures, which remains the most serious risk of this technique, although by now it is certain that such a risk is very low.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0149763419303835

Effects of online repetitive transcranial magnetic stimulation ... rTMS applied at 10 and 20 Hz both increased reaction times when applied during tasks involving attention and perception, while no significant effects were found ...

8. nimh.nih.gov nimh.nih.gov/news/media/2020/sarah-h-lisanby-transcranial-magnetic-stimulation-safety-and-risk

Sarah H. Lisanby: Transcranial Magnetic Stimulation Safety ... The safety profile of TMS is excellent. The common side effects tend to be minor and are easily managed. The serious side effects are rare and can be prevented ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/34/NCT03828734/Prot_SAP_000.pdf

PATRC Participants will perform a cognitive control task in which a retro-cue is used to distinguish between relevant and irrelevant lateralized ...

10. dukespace.lib.duke.edu dukespace.lib.duke.edu/bitstreams/4e106a34-cada-48ec-b964-44466c334eac/download

Effects of online repetitive transcranial magnetic stimulation ... Thus, the current study reports the results of a quantitative meta-analysis of online rTMS effects in the cognitive domains of at- tention, ...