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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Arrhythmic TMS, Delta TMS, Theta TMS for cognitive control?

Research shows that theta burst transcranial magnetic stimulation (TMS) can enhance cognitive control by affecting brain networks involved in attention and task performance. Studies have demonstrated that theta frequency TMS can improve connectivity in brain regions responsible for attention, leading to better performance in tasks requiring sustained attention. ^{1 2 3 4 5}

Is TMS generally safe for humans?

TMS is generally considered safe for humans, with rare occurrences of seizures being the most serious side effect, often linked to exceeding guidelines or certain medications. Most studies show no lasting negative effects on brain function, but some protocols may need further testing to ensure safety. ^{2 4 6 7 8}

How does the TMS treatment for cognitive control differ from other treatments?

The TMS treatment for cognitive control is unique because it uses transcranial magnetic stimulation (TMS) to modulate brain activity non-invasively, targeting specific brain networks like the dorsolateral prefrontal cortex (DLPFC) to enhance cognitive functions. Unlike traditional treatments, TMS can influence neural plasticity and functional connectivity, potentially leading to improved cognitive control by altering brain network interactions. ^{1 2 5 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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) 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) 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) 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]

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) 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Theta Burst Transcranial Magnetic Stimulation of Fronto-Parietal Networks: Modulation by Mental State. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The use of transcranial magnetic stimulation in cognitive neuroscience: a new synthesis of methodological issues. [2010]

3. England pubmed.ncbi.nlm.nih.gov

Assessing the mechanisms of brain plasticity by transcranial magnetic stimulation. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Alpha frequency rTMS modulates theta lagged nonlinear connectivity in dorsal attention network. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation and neuroplasticity. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Theta-burst transcranial magnetic stimulation induced functional connectivity changes between dorsolateral prefrontal cortex and default-mode-network. [2021]