rTMS for Brain Response

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Bupropion, Olanzapine, Chlorpromazine, Lithium

Disqualifiers: Neurological disease, Seizures, Psychotic, Bipolar, Substance abuse, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how repetitive transcranial magnetic stimulation (rTMS) affects brain activity and attention. Participants will perform visual tasks while receiving rTMS to the visual cortex, helping researchers understand neuroplasticity (the brain's ability to change) and the effects on attention. The trial includes different groups, with some receiving real stimulation and others sham (fake) stimulation, to compare outcomes. Individuals who speak English, are right- or left-handed, and have no history of neurological disorders like seizures might be a good fit. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research on brain function and attention.

Will I have to stop taking my current medications?

The trial requires that you do not take medications that substantially reduce the seizure threshold, such as bupropion, olanzapine, chlorpromazine, or lithium. If you are on these medications, you may need to stop taking them to participate.

What prior data suggests that repetitive transcranial magnetic stimulation is safe?

Research shows that repetitive transcranial magnetic stimulation (rTMS) is generally safe for people. Studies indicate that 1 Hz rTMS treatment is safe, with mostly mild side effects like headaches or discomfort during treatment. These effects are temporary and usually resolve on their own, with no negative impact on thinking or brain function.

Research also confirms the safety of 10 Hz rTMS treatment. It is well-tolerated, with similar mild side effects. In studies, patients experienced improvements without serious issues. Both 1 Hz and 10 Hz rTMS are non-invasive, meaning they don't require surgery or entering the body.

Overall, both types of rTMS have been used for various conditions and proven safe. Evidence suggests they are not only effective but also well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it offers a non-invasive way to modulate brain activity, unlike traditional medications or invasive procedures for neurological conditions. Researchers are excited because rTMS can precisely target specific brain regions, like the visual cortex in this trial, possibly leading to more effective treatments with fewer side effects. Additionally, rTMS can be adjusted in frequency, such as 1 Hz or 10 Hz, providing flexibility to tailor the treatment to individual needs and potentially enhancing therapeutic outcomes.

What evidence suggests that this trial's treatments could be effective?

This trial will compare different frequencies and conditions of repetitive transcranial magnetic stimulation (rTMS) on brain response. Studies have shown that rTMS can alter brain activity and aid certain conditions. Specifically, research indicates that 1 Hz rTMS, one of the frequencies tested in this trial, can adjust brain networks, potentially improving brain function. Meanwhile, 10 Hz rTMS, another frequency under study, has boosted task performance and reduced pain in some cases. It also shows promise in increasing awareness in early stages of consciousness disorders. Overall, both 1 Hz and 10 Hz rTMS offer different effects and potential benefits depending on the specific condition treated. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for men and women aged 18 to 65 who understand English well, are either left- or right-handed, and have no history of neurological disorders or seizure risks. It's not suitable for those with MRI contraindications like metal implants, unstable medical conditions, head trauma history, active substance abuse, psychotic or bipolar disorders, pregnancy/breastfeeding status, or on certain medications.

Inclusion Criteria

Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales

Left- or Right-handed

I have no history of neurological disorders.

Exclusion Criteria

I have been diagnosed with a psychotic or bipolar disorder.

Those with a contraindication for MRIs (e.g. implanted metal)

Any unstable medical condition

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo rTMS to the visual cortex and perform visual task paradigms

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in ssVEP response amplitude and visual contrast perceptual sensitivity

60 minutes

What Are the Treatments Tested in This Trial?

Interventions

• repetitive transcranial magnetic stimulation

Trial Overview

The study tests how rTMS (a non-invasive brain stimulation technique) affects the brain's plasticity using EEG to measure responses while participants do visual tasks. The effect of attention on these changes is also studied by having participants focus on different parts of a visual field during the task.

How Is the Trial Designed?

Group I: Visual Cortex, 10 Hz rTMS, Unattended Experimental Treatment 1 Intervention

Group II: Visual Cortex, 10 Hz rTMS, Attended Experimental Treatment 1 Intervention

Group III: Visual Cortex, 1 Hz rTMS, Unattended Experimental Treatment 1 Intervention

Group IV: Visual Cortex, 1 Hz rTMS, Attended Experimental Treatment 1 Intervention

Group V: Visual Cortex, Sham, Unattended Placebo Group 1 Intervention

Group VI: Visual Cortex, Sham, Attended Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

Suprathreshold rTMS over the left primary sensorimotor cortex significantly increased brain activity in the stimulated area and supplementary motor area (SMA) in most subjects, indicating effective neuronal activation.

Subthreshold rTMS did not activate the primary sensorimotor cortex but still modulated activity in remote areas like the SMA and lateral premotor cortex, suggesting it influences corticocortical connections without inducing motor responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthreshold high-frequency TMS of human primary motor cortex modulates interconnected frontal motor areas as detected by interleaved fMRI-TMS. Bestmann, S., Baudewig, J., Siebner, HR., et al.[2019]

In a preliminary study involving four patients with relapsed major depressive disorder, rapid transcranial magnetic stimulation (rTMS) showed significant improvement in depression ratings after treatment.

The results indicated that rTMS can be effectively used again in patients who had previously responded well to this therapy, suggesting its potential for repeated use in managing relapsed depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation is effective in the treatment of relapse of depression. Dannon, PN., Schreiber, S., Dolberg, OT., et al.[2022]

In a chronic stroke patient, 5 days of low-frequency rTMS on the intact motor cortex led to improvements in motor function and neuropsychological symptoms without any adverse effects.

Neuroimaging revealed that these improvements were linked to changes in brain activity, specifically a reduction in hyperactivity and reorganization in the opposite hemisphere, suggesting a mechanism of neuroplasticity that supports recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral and neuroplastic effects of low-frequency rTMS of the unaffected hemisphere in a chronic stroke patient: a concomitant TMS and fMRI study. Salatino, A., Berra, E., Troni, W., et al.[2014]

Repetitive magnetic stimulation (rTMS) is a non-invasive and painless technique that can effectively activate specific areas of the brain, making it useful for studying language, memory, and visual perception.

rTMS shows potential therapeutic benefits for conditions like movement disorders and depression, but there are safety considerations regarding its potential to induce seizures, which are addressed in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation. Possibilities, limits and safety aspects]. Brandt, SA., Ploner, CJ., Meyer, BU.[2019]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

In a study involving 9 normal volunteers, rapid-rate transcranial magnetic stimulation (rTMS) was found to be generally safe, but it caused temporary hearing threshold shifts in 3 subjects and a seizure in one subject at the highest intensity, indicating a potential risk for seizures.

The study also demonstrated that rTMS can increase cortical excitability in contralateral muscles, with the extent of this effect varying based on the intensity and frequency of the stimulation, suggesting a need for careful monitoring and guidelines to mitigate side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of rapid-rate transcranial magnetic stimulation in normal volunteers. Pascual-Leone, A., Houser, CM., Reese, K., et al.[2019]

Repetitive transcranial magnetic stimulation (rTMS) has not been thoroughly studied for side effects, with the main known risk being the acute production of seizures.

While tissue damage from rTMS is unlikely, there are concerns about potential cognitive effects and the possibility of long-term changes in brain function that have not yet been fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of repetitive transcranial magnetic stimulation. Wassermann, EM.[2005]

Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool that can effectively treat clinical depression and potentially other brain disorders, but it carries risks, including the potential to induce seizures, as evidenced by 7 known cases by 1996.

A workshop established safety guidelines for rTMS, emphasizing the importance of monitoring, ethical considerations, and the expertise required for its administration to minimize risks and enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Wassermann, EM.[2022]

Repetitive transcranial magnetic stimulation (rTMS) was found to be safe for a patient with an implanted subdural cortical electrode, showing no serious adverse effects during treatment.

Ex-vivo experiments indicated that rTMS caused only a slight increase in coil temperature and no displacement of the electrodes, suggesting that rTMS can be safely applied in clinical settings for patients with such implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. Phielipp, NM., Saha, U., Sankar, T., et al.[2019]

Citations

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Effects of repetitive transcranial magnetic stimulation and their ...

High-frequency rTMS generally refers to rTMS with a stimulation frequency greater than or equal to 5 Hz, which promotes cerebral cortical excitability, whereas ...

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frontiersin.org

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Low frequency repetitive transcranial magnetic stimulation ...

Low frequency rTMS stimulation of the right frontal cortex is as effective as high frequency rTMS stimulation of the left frontal cortex for ...

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Repetitive transcranial magnetic stimulation (rTMS) has the potential to treat brain disorders by modulating the activity of disease-specific brain networks ...

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sciencedirect.com

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Effects of online repetitive transcranial magnetic stimulation ...

Analyses were conducted separately for each cognitive domains and stratified by frequency of stimulation (1 Hz, 5 Hz, 10–19 Hz, ≥20 Hz). Outcome heterogeneity ...

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Low intensity repetitive transcranial magnetic stimulation ...

LI-rTMS induces changes in c-Fos expression that suggest modulation of neuronal activity and functional connectivity throughout the brain.

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Safety and Tolerability of Accelerated Low-Frequency ...

Repetitive Transcranial Magnetic Stimulation. All subjects received 14 sessions of rTMS (1 Hz, 30 min, 1,800 pulses, 110% RMT) to their respective motor hotspot ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/25192980/

the results from a large multicenter French RCT

Low frequency rTMS appears to be as effective as venlafaxine and as effective as the combination of both treatments for TRD.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032724018317

Efficacy and safety of low-frequency repetitive transcranial ...

LF-rTMS is generally safe, with mild adverse effects and no negative impact on neurocognitive performance for adolescents with FE-MDD.

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Efficacy of low-frequency repetitive transcranial magnetic...

This study evaluates the efficacy and safety of low-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral ...

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frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1393605/full

Efficacy and safety of low-frequency repetitive transcranial ...

The conditions of stimulation by the Mag Pro R30 transcranial magnetic stimulation device (Magventure) will be a frequency of 1-Hz, intensity of 120% motor ...