Transcranial Magnetic Stimulation for Brain Activity Study

Recruiting at 1 trial location

Overseen By Derek Nee, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: Psychiatric, Neurological, Pro-epileptic

Disqualifiers: Psychiatric, Neurological, Epilepsy, Tinnitus, others

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

Compensation: Varies

Number of Visits: 4

Duration: 3 sessions

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcranial magnetic stimulation (TMS) affects specific brain regions, namely the prefrontal cortex and posterior parietal cortex. TMS is a non-invasive treatment that uses magnetic fields to stimulate nerve cells in the brain. The study includes three groups, each receiving TMS to different brain regions to observe its impact on brain activity. Ideal participants are right-handed, native English speakers (or fluent by age six), and have no history of psychiatric or neurological conditions. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on brain stimulation techniques.

Will I have to stop taking my current medications?

If you are taking medications for psychiatric or neurological disorders, or any drugs that are pro-epileptic, you will not be eligible to participate in this trial.

What prior data suggests that transcranial magnetic stimulation is safe for brain activity studies?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe and well-tolerated. Studies have found that TMS applied to various brain areas, such as the somatosensory cortex, is painless and can safely influence brain activity. Specifically, research on TMS used on the inferior parietal lobule found it to be safe with few serious side effects, meaning most people do not experience major problems.

For the middle frontal gyrus, studies report that TMS is safe and usually does not cause serious unwanted effects. All these studies suggest TMS is safe when used correctly. However, anyone considering joining a trial should still ask the research team any questions to feel comfortable and informed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial magnetic stimulation (TMS) because it offers a non-invasive way to change brain activity, which could be particularly beneficial for conditions like depression or anxiety where current treatments often involve medication. Traditional treatments typically involve pharmaceuticals that can take weeks to show effects and may have significant side effects. Unlike these, TMS directly stimulates specific brain regions using magnetic fields, allowing for a more targeted approach. The specific techniques being explored, such as targeting the primary somatosensory cortex, the inferior parietal lobule, and the middle frontal gyrus, could lead to more personalized treatments based on individual brain activity patterns. This method could potentially provide faster relief with fewer side effects.

What evidence suggests that transcranial magnetic stimulation could be effective for brain activity?

This trial will compare the effects of transcranial magnetic stimulation (TMS) applied to different brain regions. Studies have shown that TMS effectively changes brain activity. In this trial, one group will receive TMS on the primary somatosensory cortex (S1), which research indicates can decrease the sense of touch and improve sensory and motor recovery. Another group will receive TMS on the inferior parietal lobule (IPL), which affects brain areas involved in visual and spatial tasks. A third group will receive TMS on the middle frontal gyrus (MFG), where it has been linked to better attention and thinking skills, and may even help with dementia symptoms. These findings suggest TMS can be a powerful tool for adjusting brain activity in specific areas. ^{4 6 7 8 9}

Who Is on the Research Team?

Derek Nee, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for individuals who are eligible to undergo transcranial magnetic stimulation (TMS), a non-invasive procedure. Specific eligibility criteria details are not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

Right-handed

I have been fluent in English since I was 6 years old.

Exclusion Criteria

I am not taking any medications that can cause seizures.

History of psychiatric disorders

I am taking medication for a mental health or neurological condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial fMRI session to localize TMS targets using the Comprehensive Control Task (CCT)

1 session

1 visit (in-person)

Treatment

Participants undergo 3 counter-balanced sessions of TMS targeting different brain sites, followed by fMRI

3 sessions

3 visits (in-person)

Follow-up

Participants are monitored for changes in PFC-PPC activation and behavioral performance

Immediately after intervention

What Are the Treatments Tested in This Trial?

Interventions

• transcranial magnetic stimulation

Trial Overview

The study aims to investigate the effects of TMS on two areas of the brain: the prefrontal cortex and posterior parietal cortex. The exact nature of what's being tested, such as frequency or duration of TMS, isn't specified here.

How Is the Trial Designed?

Group I: MFG-TMS Experimental Treatment 1 Intervention

Transcranial magnetic stimulation to the middle frontal gyrus. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds repeated every 10 seconds at 80% of resting motor threshold.

Group II: IPL-TMS Experimental Treatment 1 Intervention

Transcranial magnetic stimulation to the inferior parietal lobule. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds repeated every 10 seconds at 80% of resting motor threshold.

Group III: S1-TMS Active Control 1 Intervention

Transcranial magnetic stimulation to the primary somatosensory cortex. 600 pulses delivered in 50 Hz bursts every 5 Hz for 2 seconds repeated every 10 seconds at 80% of resting motor threshold.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Transcranial magnetic stimulation (TMS) is a non-invasive and painless method used since 1985 to stimulate the brain and cranial nerves, with applications in both diagnostics and treatment.

Repetitive TMS can modify the excitability of the cerebral cortex, making it a promising therapeutic tool for investigating neural circuitry and treating various neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation in clinical practice. Alisauskiene, M., Truffert, A., Vaiciene, N., et al.[2018]

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]

In a study involving 429 pediatric patients undergoing transcranial magnetic stimulation (TMS) for motor and language mapping, most adverse events were benign, with seizures occurring in 5.8% of sessions but not conclusively linked to TMS.

TMS was safely performed in patients with cranial metal, and useful mapping results were achieved in nearly all cases, indicating that TMS is a safe option for functional mapping in pediatric patients with epilepsy or brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. Braden, AA., Weatherspoon, SE., Boardman, T., et al.[2022]

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 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]

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]

Citations

1.

pnas.org

pnas.org/doi/10.1073/pnas.1113103109

Transcranial magnetic stimulation modulates the brain's ...

Two different frequencies of rTMS to the same default network node (the left posterior inferior parietal lobule, lpIPL) induced two ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6632835/

Disrupting Neural Activity to Alter and Assess Brain Function

For instance, Harris and coworkers (2008) applied short trains of 12 Hz rTMS to inferior parietal lobe, a region belonging to the dorsal visual stream ...

3.

frontiersin.org

frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2021.684367/full

Low-Frequency TMS Results in Condition-Related ...

Low-Frequency TMS Results in Condition-Related Dynamic Activation Changes of Stimulated and Contralateral Inferior Parietal Lobule. Janine Jargow* Janine Jargow ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352047723000217

Effects of repetitive transcranial magnetic stimulation and ...

... stimulation (TBS) of the left inferior parietal lobe [55]. DMN activity is inhibited as frontoparietal central executive network nodes cause the DMN to move ...

5.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0004621

Effect of Transcranial Magnetic Stimulation (TMS) on Parietal ...

Cerebral activation during planning of reaching movements occurs both ... cortex of the intraparietal sulcus or the inferior parietal lobule. Point h ...

6.

pmc.ncbi.nlm.nih.gov

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

Safety and recommendations for TMS use in healthy subjects ...

Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1041610225002431

Efficacy and safety of transcranial magnetic stimulation on ...

The reviewed studies provide favorable evidence of improved cognition with TMS across all groups with cognitive impairment. TMS was safe and well tolerated with ...

8.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/brb3.3617

Effects of repetitive transcranial magnetic stimulation of the ...

Both real and sham rTMS interventions were deemed safe and well tolerated. Notably, serious adverse events were associated with the underlying ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5518263/

Efficacy Towards Negative Symptoms and Safety of Repetitive ...

Repetitive transcranial magnetic stimulation (rTMS) is a new technique for cerebral cortex stimulation and is believed to be a safe and promising method for the ...