Transcranial Magnetic Stimulation During Cognitive Tasks for Healthy Subjects

Overseen By Aaron Mclnnes, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Minnesota

Must not be taking: Seizure medications

Disqualifiers: Psychiatric disorder, Epilepsy, Neurological condition, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 sessions

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether brain stimulation can boost mental function when combined with cognitive tasks. Participants will receive transcranial magnetic stimulation, a non-invasive brain stimulation technique, while engaging in thinking or perception tasks. Researchers will monitor changes in brain activity using EEG, which records brain waves. The trial seeks healthy individuals without diagnosed psychiatric or neurological conditions and no history of head trauma, such as a concussion. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are currently using or have recently stopped using medications that can increase the risk of seizure.

Will I have to stop taking my current medications?

The trial excludes people who are currently using medications that can increase the risk of seizure, so you may need to stop taking such medications to participate.

What is the safety track record for Transcranial Magnetic Stimulation?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe. A group of experts reviewed nearly 2,400 studies and concluded that TMS does not pose major safety risks. When used according to safety guidelines, most people tolerate it well.

Some individuals have reported mild side effects, such as headaches or scalp discomfort, which typically resolve on their own. Serious side effects are rare. The FDA has approved the treatment for conditions like major depression, further supporting its safety.

Overall, TMS is considered safe for healthy individuals when proper precautions are taken. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Transcranial Magnetic Stimulation (TMS) because it offers a non-invasive way to stimulate specific areas of the brain, which could enhance cognitive function. Unlike traditional treatments that might involve medication or therapy, TMS uses magnetic fields to target brain activity directly, potentially leading to quicker and more precise improvements in cognitive tasks. This approach could open new avenues for understanding and improving brain function in healthy individuals, which is a big leap from just managing symptoms.

What evidence suggests that transcranial magnetic stimulation is effective for enhancing mental functioning?

Research shows that transcranial magnetic stimulation (TMS) can improve thinking abilities. Studies have found that it helps with memory and language in people with Alzheimer's disease and boosts mental performance in older adults with depression. One study suggested that using TMS in a personalized way to target specific brain areas can greatly enhance thinking skills. Overall, these findings indicate that TMS can improve mental functioning by stimulating brain activity. In this trial, all participants will receive TMS during cognitive tasks to further explore its effects on mental functioning in healthy subjects. ^{6 7 8 9 10}

Who Is on the Research Team?

Alik Widge, MD, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged between 18 and 65. Participants should not be pregnant, have metal in their head (except dental fillings), diagnosed psychiatric disorders, epilepsy or history of seizures, recent concussions, adverse reactions to TMS/MRI, neurological conditions like stroke or tinnitus, or implanted medical devices.

Inclusion Criteria

Healthy controls

Exclusion Criteria

Currently pregnant

Any metal in the head (excluding mouth)

I have epilepsy or have had a seizure before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive transcranial magnetic stimulation while engaging in cognitive or perceptual tasks

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for changes in brain function using EEG after TMS

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview The study tests if engaging in cognitive or perceptual tasks while receiving transcranial magnetic stimulation (TMS) can enhance mental function. It involves two sessions where brain function changes are measured with EEG during the application of TMS.

How Is the Trial Designed?

Group I: Healthy control Experimental Treatment 1 Intervention

All participants receive the same procedures

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) applied to the right or left dorsolateral prefrontal cortex (DLPFC) negatively impacted performance on a verbal working memory task, indicating a potential temporary disruption of cognitive function.

The study revealed that rTMS not only reduced regional cerebral blood flow (rCBF) at the stimulation site but also affected distant brain regions, suggesting that rTMS can create temporary functional lesions in neural networks, leading to observable behavioral changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of the neuronal circuitry subserving working memory in healthy human subjects by repetitive transcranial magnetic stimulation. Mottaghy, FM., Krause, BJ., Kemna, LJ., et al.[2022]

In a study involving 27 healthy subjects, 10 Hz repetitive transcranial magnetic stimulation (rTMS) to the left dorsolateral prefrontal cortex significantly improved reaction times and reduced commission errors in attention tasks, indicating enhanced attentional function.

The active rTMS also led to decreased resting motor threshold and short-interval intracortical inhibition, suggesting changes in neurophysiological activity associated with the stimulation, while not affecting motor evoked potentials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attentional and neurophysiologic effects of repetitive transcranial magnetic stimulation. Kim, YW., Cui, JX., Jin, SL., et al.[2021]

In a study involving healthy subjects performing a verbal working memory task, it was found that discomfort from transcranial magnetic stimulation (TMS) correlated with increased error rates, indicating that side effects can negatively impact task performance.

The results highlight the need for researchers to control for TMS side effects in cognitive neuroscience studies to avoid misinterpretation of findings, as discomfort can bias the outcomes of the experiments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of transcranial magnetic stimulation biased task performance in a cognitive neuroscience study. Abler, B., Walter, H., Wunderlich, A., et al.[2019]

In a study involving 14 healthy subjects, repetitive transcranial magnetic stimulation (rTMS) at 20 Hz on the left prefrontal cortex significantly improved cognitive processing, as shown by decreased P3 latencies and faster reaction times.

The study demonstrated that rTMS has a measurable effect on cognitive processing, while single TMS at 1 Hz did not show any significant impact, highlighting the efficacy of rTMS over traditional stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of transcranial magnetic stimulation on cognitive processing: an event-related potential study. Evers, S., Böckermann, I., Nyhuis, PW.[2019]

In a study involving 10 healthy volunteers, repetitive transcranial magnetic stimulation (rTMS) at varying intensities (80-120% of muscle twitch threshold) showed that higher rTMS intensity inversely correlated with blood flow in the stimulated prefrontal cortex and other brain regions, indicating a unique response compared to motor cortex stimulation.

Higher intensity rTMS also led to increased blood flow in distant brain areas like the anterior cingulate and cerebellum, suggesting that stronger stimulation may enhance therapeutic effects for neuropsychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-dependent regional cerebral blood flow during 1-Hz repetitive transcranial magnetic stimulation (rTMS) in healthy volunteers studied with H215O positron emission tomography: II. Effects of prefrontal cortex rTMS. Speer, AM., Willis, MW., Herscovitch, P., et al.[2019]

Mild adverse effects (MAEs) from transcranial magnetic stimulation (TMS) occur in about 5% of sessions, with most symptoms like headache and nausea reported after the sessions, particularly during initial treatments.

The study found no significant links between participant characteristics (age and gender) or TMS parameters (frequency and intensity) and the occurrence of MAEs, suggesting that initial participant anxiety may play a role in these reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative incidence rates of mild adverse effects to transcranial magnetic stimulation. Maizey, L., Allen, CP., Dervinis, M., et al.[2022]

In a study involving 15 healthy participants, both 600 and 1200 pulses of 5-Hz rTMS significantly increased motor cortex excitability immediately and 30 minutes after stimulation, indicating its efficacy in enhancing cortical activity.

However, there was no significant difference in the effects of the two pulse conditions, suggesting a potential ceiling effect where increasing the number of pulses beyond a certain point does not further enhance cortical excitability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of different pulse numbers of transcranial magnetic stimulation on motor cortex excitability: Single-blind, randomized cross-over design. Tang, ZM., Xuan, CY., Li, X., et al.[2020]

In a study involving 6 healthy subjects, repeated short trains of rapid-rate transcranial magnetic stimulation (rrTMS) at 20 Hz and slightly above motor threshold were found to be safe, with no adverse effects on neurological, cognitive, or motor functions.

The study observed transient increases in motor evoked potentials (MEPs) in some subjects, suggesting that rrTMS may enhance cortical excitability, indicating its potential utility in studying cognitive and motor functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid rate transcranial magnetic stimulation--a safety study. Jahanshahi, M., Ridding, MC., Limousin, P., et al.[2019]

High-frequency repetitive transcranial magnetic stimulation (HF-rTMS) applied to the left dorsolateral prefrontal cortex can lead to significant cognitive improvements, particularly in patients with psychiatric or neurological disorders, compared to healthy volunteers.

The most effective stimulation parameters were found to be 10, 15, or 20 Hz over 10-15 sessions, with patients showing greater cognitive gains than healthy individuals, highlighting the need for further research to understand the underlying mechanisms and effects in various conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive effects of high-frequency repetitive transcranial magnetic stimulation: a systematic review. Guse, B., Falkai, P., Wobrock, T.[2022]

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) 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]

Citations

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The effect of transcranial magnetic stimulation on cognitive ... The results of the meta-analysis showed that TMS was significantly superior to the control group for improving the overall cognitive function of ...

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Transcranial magnetic stimulation Transcranial magnetic stimulation (TMS) is a procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of major depression.

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A New Consensus on Transcranial Magnetic Stimulation (TMS) The expert panel reviewed nearly 2,400 studies and confirmed that TMS is safe ... : Now FDA-cleared for ages 15+, with good safety data. Seniors: ...